Good manufacturing practices of artisanal products in Northeastern Brazil

Directory of Open Access Journals (Sweden)

Medeiros, J.M.S.D

2017-05-01

Full Text Available This review provides an overview of the importance of good manufacturing practices in the elaboration of artisanal products, aiming to generate a discussion about this subject. The elaboration of artisanal food has been gaining prominence in several countries of the world since these products carry the identity and culture of a place. The traditional and artisanal way of manufacturing provides the food with a variation in its characteristics, which makes it peculiar in comparison to its similar, pleasing the most diverse demands of consumers. In addition, they are considered healthier and natural foods. In the Northeast of Brazil, these products are highlighted by the significant commercialization, being sources of income generation for the region. Among the most prominent products are the coalho and butter types cheeses, bottled butter and carne de sol. Despite the economic and cultural importance of these products, the traditional way of manufacturing, without proper hygiene care, can be a limiting factor for the formal commercialization of these products. Therefore, adopting good manufacturing practices at artisanal food processing places may be the first step towards the production of higher quality products that meet the requirements of the legislation but retain their artisanal manufacturing characteristics.

78 FR 64425 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Science.gov (United States)

2013-10-29

..., 507, and 579 [Docket No. FDA-2011-N-0922] Current Good Manufacturing Practice and Hazard Analysis and... requirements for current good manufacturing practice and hazard analysis and risk-based preventive controls for..., packing, or holding of animal food in two ways. First, it would create new current good manufacturing...

Good manufacturing practices for medicinal products for human use.

Science.gov (United States)

Gouveia, Bruno G; Rijo, Patrícia; Gonçalo, Tânia S; Reis, Catarina P

2015-01-01

At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability.

Good manufacturing practices for medicinal products for human use

Science.gov (United States)

Gouveia, Bruno G.; Rijo, Patrícia; Gonçalo, Tânia S.; Reis, Catarina P.

2015-01-01

At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability. PMID:25883511

78 FR 69604 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Science.gov (United States)

2013-11-20

... Federal Register of January 16, 2013 (78 FR 3646), entitled ``Current Good Manufacturing Practice and... a proposed rule entitled ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based..., 114, 117, 120, 123, 129, 179, and 211 [Docket No. FDA-2011-N-0920] RIN 0910-AG36 Current Good...

Implementation of the Good Practices of Manufacture of PET Radiopharmaceuticals in INOR

International Nuclear Information System (INIS)

Sinconegui Gómez, Belkys; Quesada Cepero, Waldo; González González, Joaquín J.; Calderón Marín, Carlos F.; Varela Corona, Consuelo; Figueroa, Roberto

2016-01-01

The growing advance of new technologies in Nuclear Medicine such as positron emission tomography (PET) allows visualizing biological processes in vivo and provides more sensitive results in the diagnosis of oncological processes in asymptomatic stages of the disease and contribute significantly to improve cancer management. It is significant to note that these technologies include radiopharmaceuticals marked with 90 Y and 177 Lu for the therapy of patients already diagnosed by the PET technique that contribute to a significant improvement in the quality of life of patients with cancer. Our country, taking into account the importance of this technology for Health, has developed in INOR a project for the obtaining, dispensing and quality control of PET radiopharmaceuticals marked with 68 Ga for diagnosis and its therapeutic analogues marked with 177 Lu and 90Y in Conditions of Good Manufacturing Practices (GMP). The objective of the present work is to present our experiences in the implementation of the Good Practices of Manufacture of PET Radiopharmaceuticals according to regulation 16-2012 GUIDELINES ON GOOD PRACTICES OF MANUFACTURE OF PHARMACEUTICAL PRODUCTS, issued by the State Control Center for Medicines, Equipment and Devices Doctors (CECMED), a Cuban regulatory body. The implementation of the regulation considers from the preparation of personnel involved in the activity, moving through the facilities and equipment to the validation and quality control. A system for the quality assurance of the production of PET radiopharmaceuticals was implemented in accordance with Annex 5 of Regulation 16-2012 of the CECMED. This is the first experience in Cuba of the implementation of Good Manufacturing Practices of PET Radiopharmaceuticals in Hospital Radiopharmacy. The acquired experiences will be extended to the practices for the preparation of radiopharmaceuticals for the conventional Nuclear Medicine in the INOR.

Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products.

Science.gov (United States)

Tulina, M A; Pyatigorskaya, N V

2018-03-01

The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.

The added value of Good Manufacturing Practices (GMP) in the production of radiopharmaceuticals

NARCIS (Netherlands)

Gerrits, Edwin; Woerdenbag, Herman; Luurtsema, Geert; de Hooge, Marjolijn; Boersma, Hendrikus

2017-01-01

Manufacturers of medicinal products including radiopharmaceuticals have to follow regulations from their governmental organizations as well as professional societies to ensure built-in quality combined with patient safety issues. This chapter is a concise review of Good Manufacturing Practices (GMP)

78 FR 24691 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Science.gov (United States)

2013-04-26

... comments should be identified with the title ``Current Good Manufacturing Practice and Hazard Analysis and..., 114, 117, 120, 123, 129, 179, and 211 [Docket No. FDA-2011-N-0920] RIN 0910-AG36 Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of...

Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) Review and Applicability for Chemical Security Enhancements

Energy Technology Data Exchange (ETDEWEB)

Iveson, Steven W. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States). International Chemical Security Threat Reduction

2014-11-01

Global chemical security has been enhanced through the determined use and integration of both voluntary and legislated standards. Many popular standards contain components that specifically detail requirements for the security of materials, facilities and other vital assets. In this document we examine the roll of quality management standards and how they affect the security culture within the institutions that adopt these standards in order to conduct business within the international market place. Good manufacturing practices and good laboratory practices are two of a number of quality management systems that have been adopted as law in many nations. These standards are designed to protect the quality of drugs, medicines, foods and analytical test results in order to provide the world-wide consumer with safe and affective products for consumption. These standards provide no established security protocols and yet manage to increase the security of chemicals, materials, facilities and the supply chain via the effective and complete control over the manufacturing, the global supply chains and testing processes. We discuss the means through which these systems enhance security and how nations can further improve these systems with additional regulations that deal specifically with security in the realm of these management systems. We conclude with a discussion of new technologies that may cause disruption within the industries covered by these standards and how these issues might be addressed in order to maintain or increase the level of security within the industries and nations that have adopted these standards.

Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction.

Science.gov (United States)

Sheth-Shah, Radhika; Vernon, Amanda J; Seetharaman, Shankar; Neale, Michael H; Daniels, Julie T

2016-04-01

In the past decade, stem cell therapy has been increasingly employed for the treatment of various diseases. Subsequently, there has been a great interest in the manufacture of stem cells under good manufacturing practice, which is required by law for their use in humans. The cells for sight Stem Cell Therapy Research Unit, based at UCL Institute of Ophthalmology, delivers somatic cell-based and tissue-engineered therapies to patients suffering from blinding eye diseases at Moorfields Eye Hospital (London, UK). The following article is based on our experience in the conception, design, construction, validation and manufacturing within a good manufacturing practice manufacturing facility based in the UK. As such the regulations can be extrapolated to the 28 members stated within the EU. However, the principles may have a broad relevance outside the EU.

[Pharmaceutical product quality control and good manufacturing practices].

Science.gov (United States)

Hiyama, Yukio

2010-01-01

This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice.

Science.gov (United States)

Gándara, Carolina; Affleck, Valerie; Stoll, Elizabeth Ann

2018-02-01

Lentiviral vectors are used in laboratories around the world for in vivo and ex vivo delivery of gene therapies, and increasingly clinical investigation as well as preclinical applications. The third-generation lentiviral vector system has many advantages, including high packaging capacity, stable gene expression in both dividing and post-mitotic cells, and low immunogenicity in the recipient organism. Yet, the manufacture of these vectors is challenging, especially at high titers required for direct use in vivo, and further challenges are presented by the process of translating preclinical gene therapies toward manufacture of products for clinical investigation. The goals of this paper are to report the protocol for manufacturing high-titer third-generation lentivirus for preclinical testing and to provide detailed information on considerations for translating preclinical viral vector manufacture toward scaled-up platforms and processes in order to make gene therapies under Good Manufacturing Practice that are suitable for clinical trials.

Good manufacturing practice (GMP) compliance in the biologics sector: plasma fractionation.

Science.gov (United States)

Ways, J P; Preston, M S; Baker, D; Huxsoll, J; Bablak, J

1999-12-01

The U.S. blood supply is the safest it has ever been. Due to blood safety and the introduction of viral inactivation/clearance technologies, protein therapies derived from human blood have also in recent years had a history of product safety. Nevertheless, since 1995, the plasma-fractionation industry has experienced increased compliance-related actions by the Food and Drug Administration (FDA), as shown by a substantive increase in the number of FDA 483 inspectional observations, FDA warning letters and other FDA regulatory action. An evaluation of these trends shows that they reflect the implementation by the FDA of increased inspectional interest in the plasma-fractionation industry and an evolution of inspectional practices and standards of current good manufacturing practice (cGMP). Plasma fractionators have responded to FDA actions by carefully evaluating and addressing each inspectional observation, assessing impact to product and taking appropriate actions, including corrective actions to prevent future occurrence. They have made major investments in facilities, quality systems, personnel and training to meet the evolving standards of cGMP and in an effort to implement these standards systemically. Through industry associations, manufacturers have further enhanced product safety by adopting additional voluntary standards for plasma to prevent the entry of potentially unsuitable plasma into the production process. The industry remains committed to application of cGMP and to working with the FDA in further evolution of these standards while striving to assure a continued supply of safe, pure and effective plasma-derived therapies.

Good manufacturing practices production of a purification-free oral cholera vaccine expressed in transgenic rice plants.

Science.gov (United States)

Kashima, Koji; Yuki, Yoshikazu; Mejima, Mio; Kurokawa, Shiho; Suzuki, Yuji; Minakawa, Satomi; Takeyama, Natsumi; Fukuyama, Yoshiko; Azegami, Tatsuhiko; Tanimoto, Takeshi; Kuroda, Masaharu; Tamura, Minoru; Gomi, Yasuyuki; Kiyono, Hiroshi

2016-03-01

The first Good Manufacturing Practices production of a purification-free rice-based oral cholera vaccine (MucoRice-CTB) from transgenic plants in a closed cultivation system yielded a product meeting regulatory requirements. Despite our knowledge of their advantages, plant-based vaccines remain unavailable for human use in both developing and industrialized countries. A leading, practical obstacle to their widespread use is producing plant-based vaccines that meet governmental regulatory requirements. Here, we report the first production according to current Good Manufacturing Practices of a rice-based vaccine, the cholera vaccine MucoRice-CTB, at an academic institution. To this end, we established specifications and methods for the master seed bank (MSB) of MucoRice-CTB, which was previously generated as a selection-marker-free line, evaluated its propagation, and given that the stored seeds must be renewed periodically. The production of MucoRice-CTB incorporated a closed hydroponic system for cultivating the transgenic plants, to minimize variations in expression and quality during vaccine manufacture. This type of molecular farming factory can be operated year-round, generating three harvests annually, and is cost- and production-effective. Rice was polished to a ratio of 95 % and then powdered to produce the MucoRice-CTB drug substance, and the identity, potency, and safety of the MucoRice-CTB product met pre-established release requirements. The formulation of MucoRice-CTB made by fine-powdering of drug substance and packaged in an aluminum pouch is being evaluated in a physician-initiated phase I study.

Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: a novel tailored model for optimizing performance and estimating costs.

Science.gov (United States)

Abou-El-Enein, Mohamed; Römhild, Andy; Kaiser, Daniel; Beier, Carola; Bauer, Gerhard; Volk, Hans-Dieter; Reinke, Petra

2013-03-01

Advanced therapy medicinal products (ATMP) have gained considerable attention in academia due to their therapeutic potential. Good Manufacturing Practice (GMP) principles ensure the quality and sterility of manufacturing these products. We developed a model for estimating the manufacturing costs of cell therapy products and optimizing the performance of academic GMP-facilities. The "Clean-Room Technology Assessment Technique" (CTAT) was tested prospectively in the GMP facility of BCRT, Berlin, Germany, then retrospectively in the GMP facility of the University of California-Davis, California, USA. CTAT is a two-level model: level one identifies operational (core) processes and measures their fixed costs; level two identifies production (supporting) processes and measures their variable costs. The model comprises several tools to measure and optimize performance of these processes. Manufacturing costs were itemized using adjusted micro-costing system. CTAT identified GMP activities with strong correlation to the manufacturing process of cell-based products. Building best practice standards allowed for performance improvement and elimination of human errors. The model also demonstrated the unidirectional dependencies that may exist among the core GMP activities. When compared to traditional business models, the CTAT assessment resulted in a more accurate allocation of annual expenses. The estimated expenses were used to set a fee structure for both GMP facilities. A mathematical equation was also developed to provide the final product cost. CTAT can be a useful tool in estimating accurate costs for the ATMPs manufactured in an optimized GMP process. These estimates are useful when analyzing the cost-effectiveness of these novel interventions. Copyright © 2013 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

Energy Technology Data Exchange (ETDEWEB)

Razem, D; Katusin-Razem, B [Institut Rudjer Boskovic, Zagreb (Yugoslavia); Starcevic, M; Galekovic, B [PLIVA Pharmaceutical Works, Zagreb (Yugoslavia)

1990-01-01

The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author).

Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

International Nuclear Information System (INIS)

Razem, D.; Katusin-Razem, B.; Starcevic, M.; Galekovic, B.

1990-01-01

The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author)

Training small producers in Good Manufacturing Practices for the development of goat milk cheese

Directory of Open Access Journals (Sweden)

Adriana Noemí RAMÓN

Full Text Available Abstract Training in Good Manufacturing Practices enhances quality during food processing. This paper evaluates GMP training aimed at improving the chemical, sensory and microbiological quality of goat milk cheese. We worked with 26 families that produce cheese as their main source of income. Semi-structured interviews and observation were conducted to select relevant topics. The manufacturing processes were compared and samples were analyzed before and after GMP training. We trained 80% of the producers. Before receiving training, they used to make cheese from raw milk in unhygienic conditions and with little equipment. The products obtained had bad sensory characteristics, cracks, eyes on the pasta, a high number of aerobic mesophilic bacteria and total coliforms. After training, the producers pasteurized the milk and standardized processing procedures, resulting in final products that contained higher protein and calcium content, suitable sensory characteristics, and a significant reduction in microorganisms, with total coliforms falling to ≤ 5.103 UFC/g. Therefore, this study shows that the manufacturing process and the chemical, sensory and microbiological parameters of goat milk cheese improved after GMP training.

Burn patient care lost in good manufacturing practices?

Science.gov (United States)

Dimitropoulos, G.; Jafari, P.; de Buys Roessingh, A.; Hirt-Burri, N.; Raffoul, W.; Applegate, L.A.

2016-01-01

Summary Application of cell therapies in burn care started in the early 80s in specialized hospital centers world-wide. Since 2007, cell therapies have been considered as “Advanced Therapy Medicinal Products” (ATMP), so classified by European Directives along with associated Regulations by the European Parliament. Consequently, regulatory changes have transformed the standard linear clinical care pathway into a more complex one. It is important to ensure the safety of cellular therapies used for burn patients and to standardize as much as possible the cell sources and products developed using cell culture procedures. However, we can definitely affirm that concentrating the bulk of energy and resources on the implementation of Good Manufacturing Practice (GMP) alone will have a major negative impact on the care of severely burned patients world-wide. Developing fully accredited infrastructures and training personnel (required by the new directives), along with obtaining approval for clinical trials to go ahead, can be a lengthy process.We discuss whether or not these patients could benefit from cell therapies provided by standard in-hospital laboratories, thus avoiding having to meet rigid regulations concerning the use of industrial pharmaceutical products. “Hospital Exemption” could be a preferred means to offer burn patients a customized and safe product, as many adaptations may be required throughout their treatment pathway. Patients who are in need of rapid treatment will be the ones to suffer the most from regulations intended to help them. PMID:28149232

"Current Good Manufacturing Practices" and the Federal Food, Drug and Cosmetic Act

OpenAIRE

Goldstein, Beth F.

1995-01-01

The Food and Drug Administration (hereinafter, FDA) regulates food, drugs, and cosmetics in order to ensure that these products are safe and truthfully labelled. As part of its responsibilities under the Federal Food, Drug, and Cosmetic Act (hereinafter, Act), the FDA monitors the manufacturing practices of companies involved in the production of food, drugs, and medical devices. The manufacturing practices used by these companies must comply with certain standards, identified in the Act as "...

Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls. Final rule.

Science.gov (United States)

2012-03-20

The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.

Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

Science.gov (United States)

2008-07-15

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

influence of manufacturing practices on quality of pharmaceutical

African Journals Online (AJOL)

hi-tech

2004-06-01

Jun 1, 2004 ... PHARMACEUTICAL PRODUCTS MANUFACTURED IN KENYA. J. A. ORWA, L. K. ... Design: Cross-sectional study. ... of good manufacturing practices has been used in the production of each pharmaceutical product by ...

Good Manufacturing Practices and Microbial Contamination Sources in Orange Fleshed Sweet Potato Puree Processing Plant in Kenya

OpenAIRE

Malavi, Derick Nyabera; Muzhingi, Tawanda; Abong’, George Ooko

2018-01-01

Limited information exists on the status of hygiene and probable sources of microbial contamination in Orange Fleshed Sweet Potato (OFSP) puree processing. The current study is aimed at determining the level of compliance to Good Manufacturing Practices (GMPs), hygiene, and microbial quality in OFSP puree processing plant in Kenya. Intensive observation and interviews using a structured GMPs checklist, environmental sampling, and microbial analysis by standard microbiological methods were use...

Safety Profile of Good Manufacturing Practice Manufactured Interferon γ-Primed Mesenchymal Stem/Stromal Cells for Clinical Trials.

Science.gov (United States)

Guess, Adam J; Daneault, Beth; Wang, Rongzhang; Bradbury, Hillary; La Perle, Krista M D; Fitch, James; Hedrick, Sheri L; Hamelberg, Elizabeth; Astbury, Caroline; White, Peter; Overolt, Kathleen; Rangarajan, Hemalatha; Abu-Arja, Rolla; Devine, Steven M; Otsuru, Satoru; Dominici, Massimo; O'Donnell, Lynn; Horwitz, Edwin M

2017-10-01

Mesenchymal stem/stromal cells (MSCs) are widely studied by both academia and industry for a broad array of clinical indications. The collective body of data provides compelling evidence of the clinical safety of MSC therapy. However, generally accepted proof of therapeutic efficacy has not yet been reported. In an effort to generate a more effective therapeutic cell product, investigators are focused on modifying MSC processing protocols to enhance the intrinsic biologic activity. Here, we report a Good Manufacturing Practice-compliant two-step MSC manufacturing protocol to generate MSCs or interferon γ (IFNγ) primed MSCs which allows freshly expanded cells to be infused in patients on a predetermined schedule. This protocol eliminates the need to infuse cryopreserved, just thawed cells which may reduce the immune modulatory activity. Moreover, using (IFNγ) as a prototypic cytokine, we demonstrate the feasibility of priming the cells with any biologic agent. We then characterized MSCs and IFNγ primed MSCs prepared with our protocol, by karyotype, in vitro potential for malignant transformation, biodistribution, effect on engraftment of transplanted hematopoietic cells, and in vivo toxicity in immune deficient mice including a complete post-mortem examination. We found no evidence of toxicity attributable to the MSC or IFNγ primed MSCs. Our data suggest that the clinical risk of infusing MSCs or IFNγ primed MSCs produced by our two-step protocol is not greater than MSCs currently in practice. While actual proof of safety requires phase I clinical trials, our data support the use of either cell product in new clinical studies. Stem Cells Translational Medicine 2017;6:1868-1879. © 2017 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

KAJIAN PENERAPAN GOOD MANUFACTURING PRACTICE (GMP DI INDUSTRI RAJUNGAN PT.KELOLA MINA LAUT MADURA

Directory of Open Access Journals (Sweden)

Bhiaztika Ristyanadi

2016-11-01

Full Text Available Good manufacturing practice is the first step implementation of food safety regulation. PT. Kelola Mina Laut is one of chilled sea crab producers in Madura. It has four branches in Madura,those are in Tanjung Bumi, Noreh, Sampang, and Lobuk. The objective of this research is to assess the effectiveness GMP in four branches of PT. Kelola Mina Laut. The research  uses field observation, data analysis and GMP development as the method. Based on GMP analysis, four branches of PT. Kelola Mina Laut appear to have a cummulative score between 337-369, in which Lobuk has the highest score. Therefore, it can be concluded that PT. Kelola Mina Laut has applied most of GMP elements

The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research

NARCIS (Netherlands)

De Vos, FJ; De Decker, M; Dierckx, RA

Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice

Safety and quality of food contact materials. Part 1: Evaluation of analytical strategies to introduce migration testing into good manufacturing practice

DEFF Research Database (Denmark)

Feigenbaum, A.; Scholler, D.; Bouquant, J.

2002-01-01

The results of a research project (EU AIR Research Programme CT94-1025) aimed to introduce control of migration into good manufacturing practice and into enforcement work are reported. Representative polymer classes were defined on the basis of chemical structure, technological function, migration...

Modernization of the Radioisotopes Production Laboratory of the La Reina Nuclear Center in Chile: Incorporating advanced concepts of safety and good manufacturing practices

International Nuclear Information System (INIS)

Lagos Espinoza, Silvia

2014-01-01

A radioisotopes and radiopharmaceuticals production laboratory was established in Chile in the 1960s for research activities. From 1967 until January 2012, it was dedicated to the manufacturing of radioisotopes and radiopharmaceuticals for medical diagnosis and treatment purposes. In 2012, modernization of the facility’s design and technology began as part of the IAEA technical cooperation project, Modernizing the Radioisotopes Production Laboratory of La Reina Nuclear Centre by Incorporating Advanced Concepts of Safety and Good Manufacturing Practices, (CHI4022)

Inactivated human platelet lysate with psoralen: a new perspective for mesenchymal stromal cell production in Good Manufacturing Practice conditions.

Science.gov (United States)

Castiglia, Sara; Mareschi, Katia; Labanca, Luciana; Lucania, Graziella; Leone, Marco; Sanavio, Fiorella; Castello, Laura; Rustichelli, Deborah; Signorino, Elena; Gunetti, Monica; Bergallo, Massimiliano; Bordiga, Anna Maria; Ferrero, Ivana; Fagioli, Franca

2014-06-01

Mesenchymal stromal cells (MSC) are ideal candidates for regenerative and immunomodulatory therapies. The use of xenogeneic protein-free Good Manufacturing Practice-compliant growth media is a prerequisite for clinical MSC isolation and expansion. Human platelet lysate (HPL) has been efficiently implemented into MSC clinical manufacturing as a substitute for fetal bovine serum (FBS). Because the use of human-derived blood materials alleviates immunologic risks but not the transmission of blood-borne viruses, the aim of our study was to test an even safer alternative than HPL to FBS: HPL subjected to pathogen inactivation by psoralen (iHPL). Bone marrow samples were plated and expanded in α-minimum essential medium with 10% of three culture supplements: HPL, iHPL and FBS, at the same time. MSC morphology, growth and immunophenotype were analyzed at each passage. Karyotype, tumorigenicity and sterility were analyzed at the third passage. Statistical analyses were performed. The MSCs cultivated in the three different culture conditions showed no significant differences in terms of fibroblast colony-forming unit number, immunophenotype or in their multipotent capacity. Conversely, the HPL/iHPL-MSCs were smaller, more numerous, had a higher proliferative potential and showed a higher Oct-3/4 and NANOG protein expression than did FBS-MSCs. Although HPL/iHPL-MSCs exhibit characteristics that may be attributable to a higher primitive stemness than FBS-MSCs, no tumorigenic mutations or karyotype modifications were observed. We demonstrated that iHPL is safer than HPL and represents a good, Good Manufacturing Practice-compliant alternative to FBS for MSC clinical production that is even more advantageous in terms of cellular growth and stemness. Copyright © 2014 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Radiopharmaceuticals good practices handbook: ARCAL XV radiopharmaceuticals control and production

International Nuclear Information System (INIS)

Verdera Presto, Silvia

1998-01-01

A safety practice of the therapeutics diagnostic proceeding in nuclear medicine require a permanent provide high quality radiopharmaceuticals manufacture. This work treat to give a guide for all radio pharmacies laboratories that produce,control, fraction and or dispense radiopharmaceuticals products, with attention hospitable radiopharmacy laboratory. Three chapters with recommendations in manufacture good practice in Hospital radiopharmacy, industrial centralized, bibliography and three annexe's about clean area classification,standards work in laminar flux bell, and guarantee and cleaning areas

Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications.

Science.gov (United States)

Wuchter, Patrick; Bieback, Karen; Schrezenmeier, Hubert; Bornhäuser, Martin; Müller, Lutz P; Bönig, Halvard; Wagner, Wolfgang; Meisel, Roland; Pavel, Petra; Tonn, Torsten; Lang, Peter; Müller, Ingo; Renner, Matthias; Malcherek, Georg; Saffrich, Rainer; Buss, Eike C; Horn, Patrick; Rojewski, Markus; Schmitt, Anita; Ho, Anthony D; Sanzenbacher, Ralf; Schmitt, Michael

2015-02-01

Human mesenchymal stem or stromal cells (MSCs) represent a potential resource not only for regenerative medicine but also for immunomodulatory cell therapies. The application of different MSC culture protocols has significantly hampered the comparability of experimental and clinical data from different laboratories and has posed a major obstacle for multicenter clinical trials. Manufacturing of cell products for clinical application in the European Community must be conducted in compliance with Good Manufacturing Practice and requires a manufacturing license. In Germany, the Paul-Ehrlich-Institut as the Federal Authority for Vaccines and Biomedicines is critically involved in the approval process. This report summarizes a consensus meeting between researchers, clinicians and regulatory experts on standard quality requirements for MSC production. The strategy for quality control testing depends on the product's cell composition, the manufacturing process and the indication and target patient population. Important quality criteria in this sense are, among others, the immunophenotype of the cells, composition of the culture medium and the risk for malignant transformation, as well as aging and the immunosuppressive potential of the manufactured MSCs. This position paper intends to provide relevant information to interested parties regarding these criteria to foster the development of scientifically valid and harmonized quality standards and to support approval of MSC-based investigational medicinal products. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Good cell culture practices &in vitro toxicology.

Science.gov (United States)

Eskes, Chantra; Boström, Ann-Charlotte; Bowe, Gerhard; Coecke, Sandra; Hartung, Thomas; Hendriks, Giel; Pamies, David; Piton, Alain; Rovida, Costanza

2017-12-01

Good Cell Culture Practices (GCCP) is of high relevance to in vitro toxicology. The European Society of Toxicology In Vitro (ESTIV), the Center for Alternatives for Animal Testing (CAAT) and the In Vitro Toxicology Industrial Platform (IVTIP) joined forces to address by means of an ESTIV 2016 pre-congress session the different aspects and applications of GCCP. The covered aspects comprised the current status of the OECD guidance document on Good In Vitro Method Practices, the importance of quality assurance for new technological advances in in vitro toxicology including stem cells, and the optimized implementation of Good Manufacturing Practices and Good Laboratory Practices for regulatory testing purposes. General discussions raised the duality related to the difficulties in implementing GCCP in an academic innovative research framework on one hand, and on the other hand, the need for such GCCP principles in order to ensure reproducibility and robustness of in vitro test methods for toxicity testing. Indeed, if good cell culture principles are critical to take into consideration for all uses of in vitro test methods for toxicity testing, the level of application of such principles may depend on the stage of development of the test method as well as on the applications of the test methods, i.e., academic innovative research vs. regulatory standardized test method. Copyright © 2017 Elsevier Ltd. All rights reserved.

Bioenergy good practice

Energy Technology Data Exchange (ETDEWEB)

Birse, J.; Chambers, K.

2000-07-01

This report gives details of a project to make the Good Practice Guidelines, which were developed to help the UK Bioenergy industry, the national and local governments, and the public, more widely available. Details concerning the designing of a Good Practice Programme, and the proposed codes of Good Practice programme are given, and general relevant good practice guidance documents are discussed. The stakeholder survey and workshop, and the proposed codes of a Good Practice Programme are presented in Annexes. (UK)

Manufacturing best practices and performance

DEFF Research Database (Denmark)

Szász, Levente; Demeter, Krisztina; Boer, Harry

2014-01-01

whether a) home and host country characteristics moderate the association between manufacturing practices and performance, and, thus, whether b) there are manufacturing practices that are universally best. Manufacturing practices and performance are measured using data collected through the fifth round...... analysis is used to develop groups of companies based on home and host country development. Exploratory factor analysis is applied to create bundles of manufacturing practices and performance measures. Then, using moderated multiple regressions (MMR) with interaction factor, and separate multiple...... regression analyses for each group of companies, bundles of manufacturing practices are identified that lead to best-in-class performance improvements. A range of control variables is introduced to help interpret the results. The study shows that home and host country context does affect the association...

Assessment of good manufacturing practice for small scale food industry in Malang region, East Java, Indonesia

Science.gov (United States)

Purwantiningrum, I.; Widyhastuty, W.; Christian, J.; Sari, N.

2018-03-01

Enhancing food safety in developing countries, such as Indonesia, poses more challenges, especially those of the small- and medium-scale. Various food safety systems are available and readily implemented in the food industry. However, to ensure the effectiveness of such systems, pre-requisite programs should be applied prior to the implementation of food safety system. One of the most acknowledged pre-requisite program is Good Manufacturing Practices (GMP). The aim of this study is to assess the GMP compliance of some small-scale food companies in East Java. Three types of traditional food product were selected, include tempe chips, palm sugar, and instant herbal drink. A survey involving three companies for each type of traditional food was conducted. Data was obtained through observation and assessment based on tabulated criteria in GMP criteria. In essential, the result revealed the compliment level of the food companies being surveyed. There was different level of compliment between each type of the food industry, where the palm sugar industry had the lowest level of compliment compared to the other two. This difference is due to the food safety awareness, social and cultural influences, and also knowledge on food safety and hygiene practice.

Peranan Metode Activity Based Costing Dalam Menentukan Cost of Goods Manufactured

OpenAIRE

Martusa, Riki; Darma, Stephanus Ryan; Carolina, Verani

2011-01-01

The purpose of this research is to know production process of a textile company in Bandung and to analyze the comparison between cost of goods manufactured calculation methods, that applied in the company (traditional costing method) and Activity Based Costing (ABC) method. The obatained data was performed monthly during the year 2009. Based on analysis result, Cost Of Goods Manufactured calculation for unpattern material using ABC method resulted the Cost Of Goods Manufactured that is lower ...

Dietary supplement good manufacturing practices: preparing for compliance

National Research Council Canada - National Science Library

Mead, William J

2012-01-01

"Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement...

Current good manufacturing practice production of an oncolytic recombinant vesicular stomatitis viral vector for cancer treatment.

Science.gov (United States)

Ausubel, L J; Meseck, M; Derecho, I; Lopez, P; Knoblauch, C; McMahon, R; Anderson, J; Dunphy, N; Quezada, V; Khan, R; Huang, P; Dang, W; Luo, M; Hsu, D; Woo, S L C; Couture, L

2011-04-01

Vesicular stomatitis virus (VSV) is an oncolytic virus currently being investigated as a promising tool to treat cancer because of its ability to selectively replicate in cancer cells. To enhance the oncolytic property of the nonpathologic laboratory strain of VSV, we generated a recombinant vector [rVSV(MΔ51)-M3] expressing murine gammaherpesvirus M3, a secreted viral chemokine-binding protein that binds to a broad range of mammalian chemokines with high affinity. As previously reported, when rVSV(MΔ51)-M3 was used in an orthotopic model of hepatocellular carcinoma (HCC) in rats, it suppressed inflammatory cell migration to the virus-infected tumor site, which allowed for enhanced intratumoral virus replication leading to increased tumor necrosis and substantially prolonged survival. These encouraging results led to the development of this vector for clinical translation in patients with HCC. However, a scalable current Good Manufacturing Practice (cGMP)-compliant manufacturing process has not been described for this vector. To produce the quantities of high-titer virus required for clinical trials, a process that is amenable to GMP manufacturing and scale-up was developed. We describe here a large-scale (50-liter) vector production process capable of achieving crude titers on the order of 10(9) plaque-forming units (PFU)/ml under cGMP. This process was used to generate a master virus seed stock and a clinical lot of the clinical trial agent under cGMP with an infectious viral titer of approximately 2 × 10(10) PFU/ml (total yield, 1 × 10(13) PFU). The lot has passed all U.S. Food and Drug Administration-mandated release testing and will be used in a phase 1 clinical translational trial in patients with advanced HCC.

THE DYNAMICS OF BEST MANUFACTURING PRACTICES

DEFF Research Database (Denmark)

Timenes Laugen, Bjørge; Acur, Nuran; Boer, Harry

and manufacturing, and improving manufacturing process maintain their status as best practices, while servitization and supply chain management are new best practices. Globalization and responsibility are proposed as promising practices, and technology is suggested as a qualifying practice....

A practical and pyrogen-free preparation of 11C-L-methionine in a good manufacturing practice-compliant approach

Directory of Open Access Journals (Sweden)

Kang-Po Li

2017-01-01

Full Text Available Aims: 11C-L-methionine, an amino acid tracer used to delineate certain tumor tissues, has proven to be a prevailing nonfluorodeoxyglucose positron emission tomography (PET radiopharmaceutical. We intended to prepare 11C-L-methionine by following modified synthetic strategies at a rebuilt working area to meet the PET drug current good manufacturing practice (cGMP and Pharmaceutical Inspection Co-operation Scheme (PIC/S regulations. Furthermore, we overcame the problem of pyrogen cross-contamination using a cleaner and more efficient program. Material and Methods: The task of upgrading air filtration equipment was integrated with the set of Web-Based Building Automation system (WebCTRL®. 11C-L-methionine synthesis was carried out in accordance with redesigned methods to meet the requirements of PET drug cGMP. The product quality was tested by a series of quality control tests and was found to be satisfactory. Depyrogenation was carried out by three different methods with different flow rates and flushing durations. The results were examined through limulus amebocyte lysate clotting test. Results: The level of air cleanliness in each section meets the PIC/S GMP standards after the reconstructions. Moreover, after delicate modifications, the radiochemical yield of 11C-L-methionine was 36.20% ± 3.59% (based on 11C-CH3I, n = 7, which is about 10% higher than the average former yield. Besides, the used depyrogenation methods could wipe the bioburden off within 8 h. Conclusions: The modifications done not only offer a good production environment but also protect the products from contamination. The modified approaches in both 11C-L-methionine production and depyrogenation resulted in prominent progress in stability and efficiency as well.

Aid conditionalities, international Good Manufacturing Practice standards and local production rights: a case study of local production in Nepal.

Science.gov (United States)

Brhlikova, Petra; Harper, Ian; Subedi, Madhusudan; Bhattarai, Samita; Rawal, Nabin; Pollock, Allyson M

2015-06-14

Local pharmaceutical production has been endorsed by the WHO as a means of addressing health priorities of developing countries. However, local producers of essential medicines must comply with international pharmaceutical standards in order to be eligible to compete in donor tenders. These standards determine production rights for on-patent and off-patent medicines, and guide international procurement of medicines. We reviewed the literature on the impact of Good Manufacturing Practice (GMP) on local production; a gap analysis from the literature review indicated a need for further research. Over sixty interviews were conducted with people involved in the Nepali pharmaceutical production and distribution chain from 2006 to 2009 on the GMP areas of relevance: regulatory capacity, staffing, funding and training, resourcing of GMP, inspectors' interpretation of the rules and compliance. Although Nepal producers have increased their overall share of the domestic market, only the public manufacturer, Royal Drugs, focuses on medicines for public health programmes; private producers engage mainly in brand competition for private markets, not essential medicines. Nepali regulators and producers state that implementation of GMP standards is hindered by low regulatory capacity, insufficient training of staff in the industry, financial constraints and lack of investment for upgrading capital. The transition period to mandatory compliance with WHO GMP rules is lengthy. Less than half of private producers had WHO GMP in 2013. Producers are not directly affected by international harmonisation of standards as they do not export medicines and the Nepali regulator does not enforce the WHO standards strictly. Without an international GMP certificate they cannot tender for donor dependent health programmes. In Nepal, local private manufacturers focus mainly on brand competition for private consumption not essential medicines, the government preferentially procures essential

Human embryonic stem cells and good manufacturing practice: Report of a 1- day workshop held at Stem Cell Biology Research Center, Yazd, 27th April 2017

Directory of Open Access Journals (Sweden)

Fatemeh Akyash

2017-09-01

Full Text Available This report explains briefly the minutes of a 1-day workshop entitled; “human embryonic stem cells (hESCs and good manufacturing practice (GMP” held by Stem Cell Biology Research Center based in Yazd Reproductive Sciences Institute at Shahid Sadoughi University of Medical Sciences, Yazd, Iran on 27th April 2017. In this workshop, in addition to the practical sessions, Prof. Harry D. Moore from Centre for Stem Cell Biology, University of Sheffield, UK presented the challenges and the importance of the biotechnology of clinical-grade human embryonic stem cells from first derivation to robust defined culture for therapeutic applications.

Human embryonic stem cells and good manufacturing practice: Report of a 1- day workshop held at Stem Cell Biology Research Center, Yazd, 27th April 2017.

Science.gov (United States)

Akyash, Fatemeh; Sadeghian-Nodoushan, Fatemeh; Tahajjodi, Somayyeh Sadat; Nikukar, Habib; Farashahi Yazd, Ehsan; Azimzadeh, Mostafa; D Moore, Harry; Aflatoonian, Behrouz

2017-05-01

This report explains briefly the minutes of a 1-day workshop entitled; "human embryonic stem cells (hESCs) and good manufacturing practice (GMP)" held by Stem Cell Biology Research Center based in Yazd Reproductive Sciences Institute at Shahid Sadoughi University of Medical Sciences, Yazd, Iran on 27 th April 2017. In this workshop, in addition to the practical sessions, Prof. Harry D. Moore from Centre for Stem Cell Biology, University of Sheffield, UK presented the challenges and the importance of the biotechnology of clinical-grade human embryonic stem cells from first derivation to robust defined culture for therapeutic applications.

Gram-scale production of plasmid pUDK-HGF with current good manufacturing practices for gene therapy of critical limb ischemia.

Science.gov (United States)

Hu, ChunSheng; Cheng, XiaoChen; Lu, YuXin; Wu, ZuZe; Zhang, QingLin

2016-11-16

The demand of a plasmid encoding human hepatocyte growth factor gene (pUDK-HGF) in large quantities at high purity and concentration has increased for gene therapy of critical limb ischemia (CLI) in clinical trials. In this article, we produced pUDK-HGF in compliance with current good manufacturing practices at gram scale. The process included a 50-L batch fermentation, continuous alkaline lysis, and integrated three-step chromatography on Sepharose 6 Fast Flow, PlasmidSelect Xtra, and Source 15Q. The production process has been scaled up to yield 4.24 ± 0.41 g of pharmaceutical pUDK-HGF from 1.0 kg bacterial cell paste and the overall yield reached range from 58.37 to 66.70%. The final pUDK-HGF product exhibited high purity with supercoiled percentage of > 95.8% and undetectable residual RNA, contaminated protein, and bacterial endotoxin. The phase I clinical study indicates that intramuscular injection of pUDK-HGF is safe, well tolerated, and may provide symptomatic relief to CLI patients. These results show that our manufacturing process of pUDK-HGF is efficient in producing pharmaceutical-grade plasmid DNA and is safe for clinical applications.

Exploring sustainable manufacturing principles and practices

OpenAIRE

Alayón, Claudia

2016-01-01

The manufacturing industry remains a critical force in the quest for global sustainability. An increasing number of companies are modifying their operations in favor of more sustainable practices. It is hugely important that manufacturers, irrespective of the subsector they belong to, or their organizational size, implement practices that reduce or eliminate negative environmental, social and economic impacts generated by their manufacturing operations. Consequently, scholars have called for ...

Procedures development and methodology of control for application of good manufacture practices (GMP) on human blood irradiation

International Nuclear Information System (INIS)

Boghi, Claudio

2008-01-01

The irradiation of human blood is used to avoid the TA-GVHD (transfusion-associated graft-versus-host-disease), a rare but devastating adverse effect of leukocytes present in blood components for a immunocompetent transfusion recipients. Usually this irradiation practice is performed to a physical elimination of leukocytes. The implementation of the procedures will assure that the properly dose in a range of 25 Gy to 50 Gy will be delivered to the blood in the bag collected in a blood tissue bank. The studies of the procedures in order to establish a GMP (Good Manufacturing Practices) were developed under the guidelines of the standard ISO 11137 - Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization. In this work, two dosimetric systems were used for dose mapping during the studies of irradiator qualification, loading pattern, irradiation process validation and auditing. The CaS0 4 :Dy dosimeter presented difficulties concerning to uncertainty on dose measurement, stability, traceability and calibration. The PMMA and Gafchromic dosimetric systems have shown a better performance and were adopted on studies of irradiators qualification that are necessary to implementation of GMP. The irradiation tests have been done in a Gammacell 220 irradiator. The developed procedures can be adapted for different kinds of gamma irradiators, allowing implanting a quality assurance program and a GMP for blood irradiation. (author)

Cloud manufacturing: from concept to practice

Science.gov (United States)

Ren, Lei; Zhang, Lin; Tao, Fei; Zhao, Chun; Chai, Xudong; Zhao, Xinpei

2015-02-01

The concept of cloud manufacturing is emerging as a new promising manufacturing paradigm, as well as a business model, which is reshaping the service-oriented, highly collaborative, knowledge-intensive and eco-efficient manufacturing industry. However, the basic concepts about cloud manufacturing are still in discussion. Both academia and industry will need to have a commonly accepted definition of cloud manufacturing, as well as further guidance and recommendations on how to develop and implement cloud manufacturing. In this paper, we review some of the research work and clarify some fundamental terminologies in this field. Further, we developed a cloud manufacturing systems which may serve as an application example. From a systematic and practical perspective, the key requirements of cloud manufacturing platforms are investigated, and then we propose a cloud manufacturing platform prototype, MfgCloud. Finally, a public cloud manufacturing system for small- and medium-sized enterprises (SME) is presented. This paper presents a new perspective for cloud manufacturing, as well as a cloud-to-ground solution. The integrated solution proposed in this paper, including the terminology, MfgCloud, and applications, can push forward this new paradigm from concept to practice.

Implementation of Good Maufacturing Practices (GMP) in the Kitchen Hospital

OpenAIRE

Sari, Fitria Novita

2016-01-01

Abstract: Food safety is one of the important thing in public health improvement in Indonesia. Hospitals are required to keep food safety for patients by conducting the principle Good Manufacturing Practices (GMP). The purpose of this research to -identify the application of GMP in Installation Nutrition Hospital. Design of this study was using descriptive research in observational method with cross sectional design. Variables the treatment were the physical building, utility, equipment, stor...

Oficinas de boas práticas de fabricação: construindo estratégias para garantir a segurança alimentar Workshops for good manufacturing practices: building strategies for ensuring food security

Directory of Open Access Journals (Sweden)

Tarcisio da Silva Costa

2012-05-01

Full Text Available A comercialização de alimentos tradicionais resgata a história e a cultura presentes nos alimentos. Os pescadores artesanais são os principais responsáveis pelo abastecimento do mercado nacional. Considerando-se a importância da adoção de procedimentos de Boas Práticas de Fabricação em toda cadeia produtiva, o presente trabalho visa a socializar uma experiência construtiva de uma oficina de Boas Práticas de Fabricação para pescadoras. Diante disso, realizou-se um levantamento de conceitos e atitudes voltadas para produção segura de alimentos, utilizando-se como instrumento entrevistas, além da observação de seus hábitos e atitudes. Os resultados evidenciam que estas pescadoras percebem as Boas Práticas de Fabricação como sinônimo de higiene e de poder comercializar o pescado sem reclamações; porém, as mesmas não têm noção dos procedimentos de Boas Práticas de Fabricação na sua atividade. O processo formativo se constitui como uma das estratégias de base para consolidação dos grupos, sendo as oficinas alternativas eficientes, de fácil execução e baixo custo.The marketing of traditional foods recalls the history and culture in feeding. The fishermen are primarily responsible for supplying the domestic market. Considering the importance of adopting procedures for Good Manufacturing Practices throughout the production chain, this paper aims to socialize a constructive experience of a Good Manufacturing Practices workshop for fishers. Therefore, we carried out a survey of concepts and attitudes towards safe food production, using interviews as an instrument, and are observed their habits and attitudes. The results show that these Good Manufacturing Practices perceive as synonymous with health and able to market the fish without complaint, but they are not aware of the procedures for Good Manufacturing Practices activities. The training process is constituted as one of the basic strategies for strengthening

Building Skills and Qualifications among SME Employees. Leonardo da Vinci Good Practices Series.

Science.gov (United States)

Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

This document profiles 10 European programs that exemplify good practice in building skills and qualifications among employees of small and medium enterprises (SMEs). The programs profiled are as follows: (1) TRICTSME (a program providing World Wide Web-based information and communication technologies training for SMEs in manufacturing); (2)…

Good Manufacturing Practices and Microbial Contamination Sources in Orange Fleshed Sweet Potato Puree Processing Plant in Kenya.

Science.gov (United States)

Malavi, Derick Nyabera; Muzhingi, Tawanda; Abong', George Ooko

2018-01-01

Limited information exists on the status of hygiene and probable sources of microbial contamination in Orange Fleshed Sweet Potato (OFSP) puree processing. The current study is aimed at determining the level of compliance to Good Manufacturing Practices (GMPs), hygiene, and microbial quality in OFSP puree processing plant in Kenya. Intensive observation and interviews using a structured GMPs checklist, environmental sampling, and microbial analysis by standard microbiological methods were used in data collection. The results indicated low level of compliance to GMPs with an overall compliance score of 58%. Microbial counts on food equipment surfaces, installations, and personnel hands and in packaged OFSP puree were above the recommended microbial safety and quality legal limits. Steaming significantly ( P contamination. Total counts, yeasts and molds, Enterobacteriaceae, total coliforms, and E. coli and S. aureus counts in OFSP puree were 8.0, 4.0, 6.6, 5.8, 4.8, and 5.9 log 10 cfu/g, respectively. In conclusion, equipment surfaces, personnel hands, and processing water were major sources of contamination in OFSP puree processing and handling. Plant hygiene inspection, environmental monitoring, and food safety trainings are recommended to improve hygiene, microbial quality, and safety of OFSP puree.

Good Manufacturing Practices and Microbial Contamination Sources in Orange Fleshed Sweet Potato Puree Processing Plant in Kenya

Science.gov (United States)

Abong', George Ooko

2018-01-01

Limited information exists on the status of hygiene and probable sources of microbial contamination in Orange Fleshed Sweet Potato (OFSP) puree processing. The current study is aimed at determining the level of compliance to Good Manufacturing Practices (GMPs), hygiene, and microbial quality in OFSP puree processing plant in Kenya. Intensive observation and interviews using a structured GMPs checklist, environmental sampling, and microbial analysis by standard microbiological methods were used in data collection. The results indicated low level of compliance to GMPs with an overall compliance score of 58%. Microbial counts on food equipment surfaces, installations, and personnel hands and in packaged OFSP puree were above the recommended microbial safety and quality legal limits. Steaming significantly (P contamination. Total counts, yeasts and molds, Enterobacteriaceae, total coliforms, and E. coli and S. aureus counts in OFSP puree were 8.0, 4.0, 6.6, 5.8, 4.8, and 5.9 log10 cfu/g, respectively. In conclusion, equipment surfaces, personnel hands, and processing water were major sources of contamination in OFSP puree processing and handling. Plant hygiene inspection, environmental monitoring, and food safety trainings are recommended to improve hygiene, microbial quality, and safety of OFSP puree. PMID:29808161

The contribution of analytical detection methods to the enforcement of good irradiation practice

International Nuclear Information System (INIS)

Ehlermann, D.A.E.

1996-01-01

Good Manufacturing Practice (GMP) is a generally accepted principle combining several features in order to achieve the optimal quality. In other words, GMP is observed if every possible measure is taken to contribute to the best possible quality of the end product. In this sense, Good Irradiation Practice (GIP) may be understood as one of the many elements of GMP dealing especially with aspects of processing food using ionising radiation. On the contrary the operator of an irradiation facility may consider GIP as the central idea including that GMP - in this case excluding the radiation aspects - is observed in addition to GIP standards. Regardless of this theoretical dispute, it is obvious that food irradiation requires classical GMP to be applied without exception and that good practice is also applied in radiation processing. The main interest in analytical methods for the identification of radiation processed food arose from the need to enforce the ban on this process, to verify correct labelling, or to ensure that it is used only for the very limited number of application which are permitted. In this field, identification methods already introduced into the official food inspection systems have contributed considerably towards making evident several cases of the fraudulent application of radiation processing. At present, as radiation processing of food is becoming more and more accepted, the number of national clearances is increasing and the European Community is preparing for a Directive to harmonise the food laws of the member states with regard to food irradiation. Therefore, it should be considered how the analytical detection methods which have been developed could contribute to enforcing good manufacturing practices, once the main goal ceases to be the suppression of this process. (author)

Benchmarking supply chain management practices in a South African confectionery manufacturing organisation

Directory of Open Access Journals (Sweden)

Orestes Peristeris

2015-08-01

Full Text Available Background: In an increasingly competitive business world, businesses need to be able to measure the effectiveness of their supply chain management process practices against proven best practice frameworks. A number of these frameworks exist internationally but have to be used within the context of knowing the relative strengths and weaknesses of potential benchmarking frameworks. Two such frameworks were identified in the research and a case was made to use one such framework, the Global Supply Chain Forum (GSCF framework, to measure the effectiveness of the supply chain practices of a leading confectionery manufacturing company in South Africa. Objective of the research: The purpose of the research was to identify an international best practice framework, which could be used by South African manufacturing organisations to benchmark their supply chain management (SCM practices. Methodology: The methodology followed was a literature review of the existing SCM frameworks to identify a framework, which would be the most suited to the objective of the study, followed by a case study of a leading manufacturing organisation’s SCM practices benchmarked against those found in the framework. Results and conclusions: The main finding of the case study was that there is a high degree of adherence between the case study organisation’s SCM practices and those found in the SCM framework. There was also generally a high level of importance ascribed by respondents to the best practices contained by the GSCF framework. It was therefore concluded that the GSCF framework proved to be a useful instrument for a comprehensive analysis of supply chain management processes and practices for a manufacturer in the fast moving consumer goods industry, with potential for applications by organisations in the supply chains of other industries.

Do best manufacturing practices depend on the plant role in international manufacturing networks?

DEFF Research Database (Denmark)

Demeter, Krisztina; Szász, Levente; Boer, Harry

2014-01-01

. This paper investigates the relationship between plant roles and the “goodness” of manufacturing practices using the International Manufacturing Strategy Survey. According to our results plants with higher competence (leaders and contributors) have more best practices than less competent plants. Servers can...

Specifications and Quality of Technetium99m Produced diopharmaceuticals According to Good Manufacturing Practice Regulations

International Nuclear Information System (INIS)

Abudaia, Jamal; Ben Othman, Monji H.; Maatoug, Maatoug A.; Maatoug, M. Omar

2003-01-01

A Technological revolution has occurred in the last two decades of this century in field of Cold Kits preparations processed by Lyophilization technique (A drying process while frozen) which are labeled afterwards with Technetium-99m radionuclide. Such materials are intended to be used as Radiopharmaceutical probes in nuclear medicine for the diagnosis of dynamic and static conditions of organs, and therefore; uncovering of diseases and syndromes targeting humans. Preferability and the advantages of such kits labeled with Technetium-99m radionuclide over other types of radiopharmaceuticals is attributed to the unique physical properties of the radionuclide including its short half life of 6.02 hours, low photon energy of 140 keV, lacking of alpha and beta particles which are usually exposing patients to have additional exposed doses. Moreover, simplicity in obtaining such radionuclide in form portable generators containing the mother radionuclide Molybdenum - 99 (i.e. solvent extraction generators or adsorption column chromatographic generators) for-on-the- spot-labeling, and the ability of formulating the cold kits as chemical complexes located at different organs of human body. Those lyophilized kits intended for radiopharmaceutical preparations labeled with Technetium - 99m radionuclide must stand for quality assurance standards and assessments for the sake of safety, efficiency, apyrogenecity, radiochemical purity, in- vivo stability and suitability for the endeavor planed for. Therefore, in order to control and optimize those considerations, implementations of the so-called GOOD MANUFACTURING PRACTICE composed of regulations and constitutional laws related to the process of preparation and final produced preparation must take place.(author)

Manual of Good Practice in Food Irradiation. Sanitary, Phytosanitary and Other Applications

International Nuclear Information System (INIS)

2015-01-01

Ensuring that the process of irradiating food delivers the desired result consistently is essential for the correct application of the technology and will help to inspire consumer confidence in irradiated food. This publication aims to help operators of irradiation facilities to appreciate and improve their practices and also to provide detailed, yet straightforward, technical information for stakeholders such as food regulators, manufacturers and traders, who also need to understand ‘good practice’

Good Manufacturing Practices and Microbial Contamination Sources in Orange Fleshed Sweet Potato Puree Processing Plant in Kenya

Directory of Open Access Journals (Sweden)

Derick Nyabera Malavi

2018-01-01

Full Text Available Limited information exists on the status of hygiene and probable sources of microbial contamination in Orange Fleshed Sweet Potato (OFSP puree processing. The current study is aimed at determining the level of compliance to Good Manufacturing Practices (GMPs, hygiene, and microbial quality in OFSP puree processing plant in Kenya. Intensive observation and interviews using a structured GMPs checklist, environmental sampling, and microbial analysis by standard microbiological methods were used in data collection. The results indicated low level of compliance to GMPs with an overall compliance score of 58%. Microbial counts on food equipment surfaces, installations, and personnel hands and in packaged OFSP puree were above the recommended microbial safety and quality legal limits. Steaming significantly (P<0.05 reduced microbial load in OFSP cooked roots but the counts significantly (P<0.05 increased in the puree due to postprocessing contamination. Total counts, yeasts and molds, Enterobacteriaceae, total coliforms, and E. coli and S. aureus counts in OFSP puree were 8.0, 4.0, 6.6, 5.8, 4.8, and 5.9 log10 cfu/g, respectively. In conclusion, equipment surfaces, personnel hands, and processing water were major sources of contamination in OFSP puree processing and handling. Plant hygiene inspection, environmental monitoring, and food safety trainings are recommended to improve hygiene, microbial quality, and safety of OFSP puree.

Good Practices for Transforming Education

Science.gov (United States)

Benavente, Ana; Panchaud, Christine

2008-01-01

This text is a guide to the reading and interpretation of the "good practices" that are developing in the countries participating in this project and elsewhere. A systematic approach to the factors making up a "good practice" has enabled us to share our analyses in a more structured manner and to reflect on their potential for…

Good practice in the production of radiopharmaceuticals

International Nuclear Information System (INIS)

Cruz Arencibia, Jorge

2012-01-01

In the paper the evolution of concepts regarding the quality of the pharmaceutical products is analyzed in the framework of the production of radiopharmaceuticals at CENTIS. The world trends range from the quality control of the fi nal product to the comprehensive concept of quality management. It is concluded from the analysis that CENTIS has an appropriate system of Good Manufacturing Practice as a result of 15 years of systematic, growing and qualified attention to the issue, in correspondence with the world tendencies and the continuous support of CECMED, the Cuban regulatory authority. That is certified by the fact that all the production processes of CENTIS have been licensed and all the CENTIS products in the market have been registered. The existing conditions at CENTIS are favorable to establish and certificate a Quality Management System. (author)

Safety and quality of food contact materials. Part 1: evaluation of analytical strategies to introduce migration testing into good manufacturing practice.

Science.gov (United States)

Feigenbaum, A; Scholler, D; Bouquant, J; Brigot, G; Ferrier, D; Franzl, R; Lillemarktt, L; Riquet, A M; Petersen, J H; van Lierop, B; Yagoubi, N

2002-02-01

The results of a research project (EU AIR Research Programme CT94-1025) aimed to introduce control of migration into good manufacturing practice and into enforcement work are reported. Representative polymer classes were defined on the basis of chemical structure, technological function, migration behaviour and market share. These classes were characterized by analytical methods. Analytical techniques were investigated for identification of potential migrants. High-temperature gas chromatography was shown to be a powerful method and 1H-magnetic resonance provided a convenient fingerprint of plastic materials. Volatile compounds were characterized by headspace techniques, where it was shown to be essential to differentiate volatile compounds desorbed from those generated during the thermal desorption itself. For metal trace analysis, microwave mineralization followed by atomic absorption was employed. These different techniques were introduced into a systematic testing scheme that is envisaged as being suitable both for industrial control and for enforcement laboratories. Guidelines will be proposed in the second part of this paper.

Thawed chilled Barents Sea cod fillets in modified atmosphere packaging-application of multivariate data analysis to select key parameters in good manufacturing practice

DEFF Research Database (Denmark)

Bøknæs, Niels; Jensen, K.N.; Guldager, H.S.

2002-01-01

The purpose of the present study was to select key parameters in good manufacturing practice for production of thawed chilled modified atmosphere packed (MAP) cod (Gadus morhua) fillets. The effect of frozen storage temperature (-20 and -30 C), frozen storage period (3, 6, 9 and 12 mo) and chill...... storage periods up to 21 d at 2 C were evaluated for thawed MAP Barents Sea cod fillets. Sensory, chemical, microbiological and physical quality attributes were evaluated and multivariate data analysis (principal component analysis and partial least- squares regression) applied for identification of key...... storage was low for thawed MAP Barents Sea cod and this fish raw material seemed the more appropriate for production of thawed chilled MAP products. Frozen storage inactivation of the spoilage bacteria of Photobacterium phosphorcum was modest in Barnets Sea cod, possibly due to high trimethylamine oxide...

The Profile of Good Hygiene Practice of Catering Service Sector in Samsun

OpenAIRE

Sibel Özçakmak; Osman Gül

2016-01-01

Before serving the meals, the managements that operate in the production and distribution of table d’hôte meals, the data related to whether it's appropriate for the food hygiene regulation and the other legal requirements are so insufficient. So, an interview study was performed for the present conditions of the manufactures producing and serving meals and the good hygiene practices profile of their working personal in the plants with regard to Law No.5966 on Veterinary Services, Plant healt...

Rules for the certification of good practices in clinical laboratories. No regulation. 3-2009. Good Laboratory Practice

International Nuclear Information System (INIS)

2015-01-01

Regulation for Certification of Good Practices in clinical laboratories, hereinafter Regulation establishes the methodology and procedures for clinical laboratories to demonstrate their state of compliance with good practices, according to Regulation 3-2009, and that the CECMED can verify.

Radiopharmaceuticals good practices handbook: ARCAL XV radiopharmaceuticals control and production; Manual de buenas practicas radiofarmaceuticas: ARCAL XV produccion y control de radiofarmacos

Energy Technology Data Exchange (ETDEWEB)

Verdera Presto, Silvia [comp.; Universidad de la Republica, Facultad de ciencias, Centro de Investigaciones Nucleares, Montevideo (Uruguay)

1999-12-31

A safety practice of the therapeutics diagnostic proceeding in nuclear medicine require a permanent provide high quality radiopharmaceuticals manufacture. This work treat to give a guide for all radio pharmacies laboratories that produce,control, fraction and or dispense radiopharmaceuticals products, with attention hospitable radiopharmacy laboratory. Three chapters with recommendations in manufacture good practice in Hospital radiopharmacy, industrial centralized, bibliography and three annexe`s about clean area classification,standards work in laminar flux bell, and guarantee and cleaning areas

Simple, cost effective & result oriented framework for supplier performance measurement in sports goods manufacturing industry

Directory of Open Access Journals (Sweden)

2011-09-01

Full Text Available The emergences of global markets have increased competition worldwide. For the Sports Goods Manufacturing Industry which is considered to be an intensive supplier base industry with limited resources to sustain in what is already a very competitive market there is a need for the entire supply chain viz. raw material and machinery suppliers and manufacturers to measure their supplier's performance to reduce business risks and revenue losses. How to design & execute a simple, cost effective & result oriented Framework for Supplier Performance Measurement for sports goods manufacturing small - medium enterprises is the main aim of this research paper.

2 CFR 176.160 - Award term-Required Use of American Iron, Steel, and Manufactured Goods (covered under...

Science.gov (United States)

2010-01-01

... award term and condition— Designated country—(1) A World Trade Organization Government Procurement..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... Award term—Required Use of American Iron, Steel, and Manufactured Goods (covered under International...

HEALTH TECHNOLOGY ASSESSMENT FOR DECISION MAKING IN LATIN AMERICA: GOOD PRACTICE PRINCIPLES.

Science.gov (United States)

Pichon-Riviere, Andrés; Soto, Natalie C; Augustovski, Federico Ariel; García Martí, Sebastián; Sampietro-Colom, Laura

2018-06-11

The aim of this study was to identify good practice principles for health technology assessment (HTA) that are the most relevant and of highest priority for application in Latin America and to identify potential barriers to their implementation in the region. HTA good practice principles proposed at the international level were identified and then explored during a deliberative process in a forum of assessors, funders, and product manufacturers. Forty-two representatives from ten Latin American countries participated. Good practice principles proposed at the international level were considered valid and potentially relevant to Latin America. Five principles were identified as priority and with the greatest potential to be strengthened at this time: transparency in the production of HTA, involvement of relevant stakeholders in the HTA process, mechanisms to appeal decisions, clear priority-setting processes in HTA, and a clear link between HTA and decision making. The main challenge identified was to find a balance between the application of these principles and the available resources in a way that would not detract from the production of reports and adaptation to the needs of decision makers. The main recommendation was to progress gradually in strengthening HTA and its link to decision making by developing appropriate processes for each country, without trying to impose, in the short-term, standards taken from examples at the international level without adequate adaptation of these to local contexts.

Manufacturing technology for practical Josephson voltage normals

International Nuclear Information System (INIS)

Kohlmann, Johannes; Kieler, Oliver

2016-01-01

In this contribution we present the manufacturing technology for the fabrication of integrated superconducting Josephson serial circuits for voltage normals. First we summarize some foundations for Josephson voltage normals and sketch the concept and the setup of the circuits, before we describe the manufacturing technology form modern practical Josephson voltage normals.

Assessment of the readiness of SME to entering the modern market by using the good manufacturing practice and halal assurance system (Case study on Sari Murni SME)

Science.gov (United States)

Dewantara, Achmad Samudra; Liquiddanu, Eko; Rosyidi, Cucuk Nur; Hisjam, Muh.; Yuniaristanto

2018-02-01

Sari Murni (SM) is one of the SME that produces tofu in Krajan Surakarta. In the process of marketing, The SM sells their product to traditional market and has made an attempt to enter modern market. One of the requirement of tofu product to enter the modern market is that tofu product must have a GMP licence (household industry licence). A benchmarking is conducted to compare the production process of SM with other established tofu producer intern of good manufacturing practice (GMP). The basic aim of GMP is concern with the precaution needed to ensure all quality and safety basic requirement (Rotaru dkk, 2005). In addition, the halal licence is also an important requirement for a product to enter the modern market. To obtain the halal licence it is necessary to first assess the performance of halal assurance of the SME. If the grade of performance halal of halal assurance system is below the B level then the SME will not be able to get halal licence. Based on the result, the level of the non-conformity of good manufacturing practice (GMP) in SM is 4 and the result of halal assurance system for SM is C.so according to the result, SM needs to make some improvement to reduce the level of non-conformity of the GMP and improve the performance of halal assurance system in order to obtain a minimum grade. To start the improvement then the analysis of HACCP (hazard analysis critical control point) is performed to determine the location of critical point which has the possibility to contaminate the tofu product so after mapping the location of critical control point then the SM can make improvement intern of equipment process and environment.

Manual of Good Practice in Food Irradiation. Sanitary, Phytosanitary and Other Applications (Spanish Edition)

International Nuclear Information System (INIS)

2017-01-01

Ensuring that the process of irradiating food delivers the desired result consistently is essential for the correct application of the technology and will help to inspire consumer confidence in irradiated food. This publication aims to help operators of irradiation facilities to appreciate and improve their practices and also to provide detailed, yet straightforward, technical information for stakeholders such as food regulators, manufacturers and traders, who also need to understand ‘good practice’.

Factors affecting workers' delivery of good hygienic and sanitary ...

African Journals Online (AJOL)

ADEYEYE

2015-03-06

Mar 6, 2015 ... adhere to Good Manufacturing Practices (GMP) and. Good Hygiene Practices ... has resulted in meat contamination and poor waste disposal, with ... and other food animals arrive these slaughterhouses from various parts of ...

40 CFR 59.603 - How must manufacturers apply good engineering judgment?

Science.gov (United States)

2010-07-01

... engineering judgment? 59.603 Section 59.603 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... COMMERCIAL PRODUCTS Control of Evaporative Emissions From New and In-Use Portable Fuel Containers Overview and Applicability § 59.603 How must manufacturers apply good engineering judgment? (a) In addition to...

As boas práticas de fabricação de medicamentos e suas determinantes | Good manufacturing practices of medicines and their determinants

Directory of Open Access Journals (Sweden)

Marcelo Vogler

2017-05-01

Full Text Available As Boas Práticas de Fabricação (BPF garantem que os medicamentos sejam consistentemente produzidos e controlados de acordo com padrões de qualidade previamente estabelecidos. Têm por objetivo gerenciar e minimizar os riscos inerentes à fabricação de medicamentos com vista a garantir a qualidade, eficácia e segurança do produto acabado. Desde o seu surgimento da forma como conhecemos hoje, várias versões se sucederam no Brasil e no mundo. Esse trabalho se propõe a analisar as BPF, por meio da análise de conteúdo dos marcos regulatórios brasileiros, identificando as determinantes que podem explicar a sua evolução através das últimas décadas. As BPF foram decompostas em temas e subtemas e suas versões, presentes nos cinco marcos regulatórios estudados, foram avaliadas. Foi possível comprovar, na evolução dos requisitos de fabricação de medicamentos, a interferência da inovação tecnológica e a influência de novas práticas relacionadas à qualidade, identificando, dessa forma, a dinâmica de transformação das BPF. ==================================================Good Manufacturing Practices (GMP ensure that drugs are consistently produced and controlled according to previously established quality standards. They are designed to manage and minimize the inherent risks involved in the manufacture of drugs in order to ensure the quality, efficacy and safety of the finished product. Since their inception as we know them today, several versions have taken place in Brazil and worldwide. This work proposes to analyze GMP, through the analysis of the content of Brazilian regulatory frameworks, identifying the determinants that can explain their evolution over the last decades. GMP were broken down into topics and subtopics and their versions present in the five regulatory frameworks studied were evaluated. It was possible to verify, in the evolution of drug manufacturing requirements, the interference of technological

Good manufacturing practice-compliant expansion of marrow-derived stem and progenitor cells for cell therapy.

Science.gov (United States)

Gastens, Martin H; Goltry, Kristin; Prohaska, Wolfgang; Tschöpe, Diethelm; Stratmann, Bernd; Lammers, Dirk; Kirana, Stanley; Götting, Christian; Kleesiek, Knut

2007-01-01

production of good manufacturing practice (GMP)-compliant cell therapeutics, ready for use within a clinical setting, with minimal risk of microbial contamination.

Integrating Education: Parekhian Multiculturalism and Good Practice

Science.gov (United States)

McGlynn, Claire

2009-01-01

This paper explores the concept of good practice in integrating education in divided societies. Using Northern Ireland as a case study, the paper draws on data from eight schools (both integrated Catholic and Protestant, and separate) that are identified as exemplifying good practice in response to cultural diversity. Analysis is provided through…

Quantification of the islet product: presentation of a standardized current good manufacturing practices compliant system with minimal variability.

Science.gov (United States)

Friberg, Andrew S; Brandhorst, Heide; Buchwald, Peter; Goto, Masafumi; Ricordi, Camillo; Brandhorst, Daniel; Korsgren, Olle

2011-03-27

Accurate islet quantification has proven difficult to standardize in a good manufacturing practices (GMP) approved manner. The influence of assessment variables from both manual and computer-assisted digital image analysis (DIA) methods were compared using calibrated, standardized microspheres or islets alone. Additionally, a mixture of microspheres and exocrine tissue was used to evaluate the variability of both the current, internationally recognized, manual method and a novel GMP-friendly purity- and volume-based method (PV) evaluated by DIA in a semiclosed, culture bag system. Computer-assisted DIA recorded known microsphere size distribution and quantities accurately. By using DIA to evaluate islets, the interindividual manually evaluated percent coefficients of variation (CV%; n=14) were reduced by almost half for both islet equivalents (IEs; 31% vs. 17%, P=0.002) and purity (20% vs. 13%, P=0.033). The microsphere pool mixed with exocrine tissue did not differ from expected IE with either method. However, manual IE resulted in a total CV% of 44.3% and a range spanning 258 k IE, whereas PV resulted in CV% of 10.7% and range of 60 k IE. Purity CV% for each method were similar approximating 10.5% and differed from expected by +7% for the manual method and +3% for PV. The variability of standard counting methods for islet samples and clinical quantities of microspheres mixed with exocrine tissue were reduced with DIA. They were reduced even further by use of a semiclosed bag system compared with standard manual counting, thereby facilitating the standardization of islet evaluation according to GMP standards.

Conservation of filtering in manufacturing systems with unreliable machines and finished goods buffers

Directory of Open Access Journals (Sweden)

Jingshan Li

2006-01-01

nature of manufacturing systems, this law offers a tool for selecting the smallest, that is, lean, finished goods buffering, which is necessary and sufficient to ensure the desired level ofcustomer demand satisfaction.

After-sales service to manufactured goods on technological basis

Directory of Open Access Journals (Sweden)

Miriam Borchardt

2008-07-01

Full Text Available This theoretical and exploratory paper aims to build a critical analysis on after-sales services, mainly regarded to manufactured goods on technological basis. The purpose of the research is to achieve some better understanding about the essential elements that are to be taken into account in conceiving such a service, after different approaches. After-sales service is a member of the service package and it can influence customer satisfaction. The studied issues can integrate policies to guiding firms in designing after-sales services. They are: definition of the service itself; strategic issues; the facilities and premises; and the operation management. We aim this theoretical research to be a pre-requisite to launch further empirical researches, mainly in the field of inter-organizational relationships. Key-words: service management; after-sales service; service operations; goods associated to services; inter-organizational relationships.

21 CFR 1271.150 - Current good tissue practice requirements.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part set...

Good Laboratory Practice. Part 3. Implementing Good Laboratory Practice in the Analytical Lab

Science.gov (United States)

Wedlich, Richard C.; Pires, Amanda; Fazzino, Lisa; Fransen, Joseph M.

2013-01-01

Laboratories submitting experimental results to the Food and Drug Administration (FDA) or the Environmental Protection Agency (EPA) in support of Good Laboratory Practice (GLP) nonclinical laboratory studies must conduct such work in compliance with the GLP regulations. To consistently meet these requirements, lab managers employ a "divide…

[Evaluation of good manufacturing practices in the elaboration of enteral formulas in public hospitals of Santiago (Chile)].

Science.gov (United States)

Lara González, Sandra; Domecq Jendres, C; Atalah Samur, Eduardo

2013-11-01

The development of enteral formulas (FE) is subject to various risks of contamination. The World Health Organization (WHO) and the Food and Agriculture Organization (FAO), have worried about alerting, recommendations and documents released to prevent contamination the FE, suggesting the standardization and protocols for all procedures involved. The study was aimed to evaluate compliance with the technical criteria contained in a Guideline for Good Practice of Manufacture in relation to the development, maintenance and administration of enteral nutrition in hospitals of Santiago, in the Metropolitan Area. The verification criteria considered Physical Plant, Equipment and Implementation, Hygienic and Sanitary Standards, Human Resources, Organization and Management, Safety and Warranty Quality Assurance. 639 criteria were defined, 309 risk Type 1, by mayor risk of producing pollution. The study was conducted by observing Central Units Enteral Formulas and interview with the caregiver. Medium of compliance for each group of criteria risk 1 and overall, was analyzed. A total of 14 public hospitals were studied. The degree of compliance with the 639 reached a median of 33.2% (p25-75 31.6%-40.4%), with the lowest value for physical plant with 27.9% (p25-75 23.9%-38.2%) and the highest for human resources with 52.4% (p25-75 44.1%-52.4%). Median compliance for risk criteria Type 1 was only 31.8% (p25-75 27.5%-41.2%). Most of the units tested, meets less than half of the internationals recommendations, or the Ministry of Health of Chile. It should develop protocols and train staff to ensure quality and safety in the development of enteral formulas and reduce risk of infection. Copyright AULA MEDICA EDICIONES 2013. Published by AULA MEDICA. All rights reserved.

Impact of Company Size on Manufacturing Improvement Practices: An empirical study

International Nuclear Information System (INIS)

Syan, C S; Ramoutar, K

2014-01-01

There is a constant search for ways to achieve a competitive advantage through new manufacturing techniques. Best performing manufacturing companies tend to use world-class manufacturing (WCM) practices. Although the last few years have witnessed phenomenal growth in the use of WCM techniques, their effectiveness is not well understood specifically in the context of less developed countries. This paper presents an empirical study to investigate the impact of company size on improving manufacturing performance in manufacturing organizations based in Trinidad and Tobago (T and T). Empirical data were collected via a questionnaire survey which was send to 218 manufacturing firms in T and T. Five different company sizes and seven different industry sectors were studied. The analysis of survey data was performed with the aid of Statistical Package for Social Sciences (SPSS) software. The study signified facilitating and impeding factors towards improving manufacturing performance. Their relative impact/importance is dependent on varying company size and industry sectors. Findings indicate that T and T manufacturers are still practicing traditional approaches, when compared with world class manufacturers. In the majority of organizations, these practices were not 100% implemented even though they started the implementation process more than 5 years ago. The findings provided some insights in formulating more optimal operational strategies, and later develop action plans towards more effective implementation of WCM in T and T manufacturers

Impact of Company Size on Manufacturing Improvement Practices: An empirical study

Science.gov (United States)

Syan, C. S.; Ramoutar, K.

2014-07-01

There is a constant search for ways to achieve a competitive advantage through new manufacturing techniques. Best performing manufacturing companies tend to use world-class manufacturing (WCM) practices. Although the last few years have witnessed phenomenal growth in the use of WCM techniques, their effectiveness is not well understood specifically in the context of less developed countries. This paper presents an empirical study to investigate the impact of company size on improving manufacturing performance in manufacturing organizations based in Trinidad and Tobago (T&T). Empirical data were collected via a questionnaire survey which was send to 218 manufacturing firms in T&T. Five different company sizes and seven different industry sectors were studied. The analysis of survey data was performed with the aid of Statistical Package for Social Sciences (SPSS) software. The study signified facilitating and impeding factors towards improving manufacturing performance. Their relative impact/importance is dependent on varying company size and industry sectors. Findings indicate that T&T manufacturers are still practicing traditional approaches, when compared with world class manufacturers. In the majority of organizations, these practices were not 100% implemented even though they started the implementation process more than 5 years ago. The findings provided some insights in formulating more optimal operational strategies, and later develop action plans towards more effective implementation of WCM in T&T manufacturers.

International Good Practice on Practical Implementation of Characterisation in Decommissioning. Radiological Characterization in Decommissioning of Nuclear Facilities: International Good Practice on Practical Implementation

International Nuclear Information System (INIS)

Larsson, A.; Empdage, M.; Weber, I.; )

2017-01-01

Within the Nuclear Energy Agency (NEA), the Working Party on Decommissioning and Dismantling (WPDD) operates under the umbrella of the Radioactive Waste Management Committee (RWMC). The WPDD provides a focus for the analysis of decommissioning policy, strategy and regulation, including the related issues of waste management, release of buildings and sites from regulatory control and associated cost estimation and funding. WPDD also convenes task groups comprised of experts from the NEA member countries to review related topics such as characterisation techniques which support decommissioning and associated waste management. The Task Group on Radiological Characterisation and Decommissioning was established in 2011 to identify and present characterisation good practice at different stages of decommissioning and to identify areas that could, or should, be developed further through international cooperation and coordination. By the end of 2016 two phases of work will be complete. The first phase developed strategic guidance for decision makers on the selection and tailoring of strategies for radiological characterisation, which gives an overview of good practice for radiological characterisation at different phases of the life cycle of a nuclear installation. The second phase has focused on strategies for practical implementation of radiological characterisation from a waste and materials end-state perspective. This paper provides a summary of the phase 2 findings, covering: -) a major international survey (questionnaire) to elicit the views of characterisation experts regarding good practice; -) Learning drawn from recent international case studies; -) The collation and analysis of regulations, standards and guidance documents; -) Learning distilled from an international conference on characterisation co-organised by the task group; and -) Overall conclusions regarding characterisation good practice, recommendations and identified areas for further international

New workplace practices and firm performance in manufacturing:

DEFF Research Database (Denmark)

Pozzoli, Dario; Cristini, Annalisa

Using data from the 2004 Workplace Employee Relations Survey on British establishments and two surveys on manufacturing firms located in the North of Italy, we look at the diffusion of new workplace practices in the two countries and at their impact on the firm's performance. We find that the Ita......Using data from the 2004 Workplace Employee Relations Survey on British establishments and two surveys on manufacturing firms located in the North of Italy, we look at the diffusion of new workplace practices in the two countries and at their impact on the firm's performance. We find...... that the Italian and British samples differ more in terms of composition of the set practices than in terms of overall incidence, but the statistical associations between some of the practices and the firm's performance are robust across countries. The counterfactual analysis shows that could the Italian firms...

Sustainable Manufacturing Practices in Malaysian Automotive Industry: Confirmatory Factor Analysis

OpenAIRE

Habidin, Nurul Fadly; Zubir, Anis Fadzlin Mohd; Fuz, Nursyazwani Mohd; Latip, Nor Azrin Md; Azman, Mohamed Nor Azhari

2015-01-01

Sustainable manufacturing practices (SMPs) have received enormous attention in current years as an effective solution to support the continuous growth and expansion of the automotive manufacturing industry. This reported study was conducted to examine confirmatory factor analysis for SMP such as manufacturing process, supply chain management, social responsibility, and environmental management based on automotive manufacturing industry. The results of confirmatory factor analysis show that fo...

Good practices in early childhood education:

DEFF Research Database (Denmark)

Sanders, Lise; Gregoriadis, Athanasis; Zachopoulou, Evridiki

Good practices in early childhood education er en undersøgelse fortaget efter Early Childhood Environmental Rating Scale - R (ECERS-R). I undersøgelsen deltog Akademikere, pædagoger og kommunalt personale fra de 6 partnerlande bestående af Grækenland, Portugal, Finland, Danmark, Rumænien og Cypern....... Undersøgelsen fokuserede på indsamling af Good practice inden for 5 specifikke kategorier af daglig praksis i børnehaver og børnehaveklasser. Plads og Inventar Personlige omsorgsrutiner Sprog - Tænkning Aktiviteter Interaktioner Struktur Projektet er støttet af Lifelong learning programme of the European Union...

Modular glovebox connector and associated good practices for control of radioactive and chemically toxic materials

International Nuclear Information System (INIS)

Hoover, M.D.; Mewhinney, C.J.; Newton, G.J.

1999-01-01

Design and associated good practices are described for a modular glovebox connector to improve control of radioactive and chemically toxic materials. The connector consists of an anodized aluminum circular port with a mating spacer, gaskets, and retaining rings for joining two parallel ends of commercially available or custom-manufactured glovebox enclosures. Use of the connector allows multiple gloveboxes to be quickly assembled or reconfigured in functional units. Connector dimensions can be scaled to meet operational requirements for access between gloveboxes. Options for construction materials are discussed, along with recommendations for installation of the connector in new or retrofitted systems. Associated good practices include application of surface coatings and caulking, use of disposable glovebags, and proper selection and protection of gasket and glove materials. Use of the connector at an inhalation toxicology research facility has reduced the time and expense required to reconfigure equipment for changing operational requirements, the dispersion of contamination during reconfigurations, and the need for decommissioning and disposal of contaminated enclosures

Supply chain management practices in a leading manufacturing organization

OpenAIRE

2014-01-01

M.Com. (Logistics Management) Within the increasingly competitive global economic environment, organisations need to find ways of increasing their competitiveness. This trend has been felt strongly by South African manufacturing organisations as a result of the liberalization of the South African economy, particularly the relaxation of tariff and trade barriers, and the reduction in the cost of international trade leading to the importation of manufactured goods from both developed and eme...

Top 10 metrics for life science software good practices.

Science.gov (United States)

Artaza, Haydee; Chue Hong, Neil; Corpas, Manuel; Corpuz, Angel; Hooft, Rob; Jimenez, Rafael C; Leskošek, Brane; Olivier, Brett G; Stourac, Jan; Svobodová Vařeková, Radka; Van Parys, Thomas; Vaughan, Daniel

2016-01-01

Metrics for assessing adoption of good development practices are a useful way to ensure that software is sustainable, reusable and functional. Sustainability means that the software used today will be available - and continue to be improved and supported - in the future. We report here an initial set of metrics that measure good practices in software development. This initiative differs from previously developed efforts in being a community-driven grassroots approach where experts from different organisations propose good software practices that have reasonable potential to be adopted by the communities they represent. We not only focus our efforts on understanding and prioritising good practices, we assess their feasibility for implementation and publish them here.

[What everybody should know about good clinical practices].

Science.gov (United States)

Osorio, Lyda

2015-01-01

An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings.

Good and bad practices in pv plants

OpenAIRE

Martinez Moreno, Francisco; Helleputte, F.; Tyutyundzhiev, N.; Rabal Echeverria, Daniel; Conlon, Michael; Fartaria, Tomás; Oteiza, David

2013-01-01

The PVCROPS project (PhotoVolta ic Cost r€duction, Reliability, Operational performance, Prediction and Simulation), cofinanced by European Commission in the frame of Seventh Framework Programme, has compiled in the “Good and bad practices: Manual to improve the quality and reduce the cost of PV systems” a collection of good and bad practices in actual PV plants . All the situations it collects represent the state-of-the-art of existing PV installations all around Europe. They show how ...

Information manual on the microbiological aspects of good manufacturing practices for radiopharmaceutical preparations

International Nuclear Information System (INIS)

Saunders, M.

1985-04-01

A description is given of clean air units, clean room garments, disinfectants and types of contamination likely to affect radiopharmaceutical preparations and measures for their control. Specific precautions for the manufacture at Lucas Heights of sterile, pyrogen-free injectables and oral preparations of low microbial contamination are described

Practical Aspects of CALS in Design and Manufacturing of Sheet Metal Products

DEFF Research Database (Denmark)

Shpitalni, Moshe; Alting, Leo; Bilberg, Arne

1998-01-01

The transition from design to process planning and to the various stages of manufacturing is traditionally sequential. In many cases, practical problems associated with manufacturing cannot be resolved if only individual processes are examined. These problems can be overcome, however, by adopting...... with the design and manufacture of sheet metal parts. It is demonstrated that through implementation of the CALS approach, the overall process can be optimised and products can be manufactured significantly more accurately, faster and less expensively.......The transition from design to process planning and to the various stages of manufacturing is traditionally sequential. In many cases, practical problems associated with manufacturing cannot be resolved if only individual processes are examined. These problems can be overcome, however, by adopting...

Conservation of filtering in manufacturing systems with unreliable machines and finished goods buffers

Directory of Open Access Journals (Sweden)

2006-01-01

Full Text Available This paper addresses the issue of reliable satisfaction of customer demand by unreliable production systems. In the framework of a simple production-storage-customer model, we show that this can be accomplished by using an appropriate level of filtering of production randomness. The filtering is ensured by finished goods buffers (filtering in space and shipping periods (filtering in time. The following question is considered: how are filtering in space and filtering in time interrelated? As an answer, we show that there exists a conservation law: in lean manufacturing systems, the amount of filtering in space multiplied by the amount of filteringin time (both measured in appropriate dimensionless units ispractically constant. Along with providing an insight into the nature of manufacturing systems, this law offers a tool for selecting the smallest, that is, lean, finished goods buffering, which is necessary and sufficient to ensure the desired level ofcustomer demand satisfaction.

Good practices for outage management in nuclear power plants

International Nuclear Information System (INIS)

1991-09-01

As a follow-up to an earlier Technical Document on Good Practices for Improved Nuclear Power Plant Performance (IAEA-TECDOC-498), the Agency has produced a more focused technical report on good practices associated with nuclear power plant outage planning and execution. As with the earlier document, the overall aim is that by identifying good practices in the key aspects of outage management, overall world nuclear performance will improve and the gap between excellent performers and operators with developing programmes will be narrowed. This document has been produced through the contribution of numerous operators and government agencies. It aims at minimizing text and focusing on actual good practices in use which can be found in the annexes. While the specific methods used to achieve excellence in maintenance/refuelling outages may differ, the fundamental requirements of outage management are discussed

Performance management practices in lean manufacturing organizations

NARCIS (Netherlands)

Bellisario, Andrea; Pavlov, Andrey

2018-01-01

This paper provides the first systematic look into the existing research on performance management (PM) practices employed in lean manufacturing organisations (LMOs). It adopts a systematic review method to examine the evidence generated in the period 2004 – 2015 and uses a comprehensive PM

40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

Science.gov (United States)

2010-07-01

... engineering judgment in making all decisions called for under this subpart, including but not limited to... overlooked, that the decision was not made in good faith, or that the decision was not made with a rational... judgment to manufacturers' decisions. 86.1851-01 Section 86.1851-01 Protection of Environment ENVIRONMENTAL...

Producers' approaches about good agricultural practices in Manisa and İzmir

Directory of Open Access Journals (Sweden)

Karabat Selcuk

2017-01-01

Full Text Available This study includes the agricultural enterprises which apply and do not apply good agricultural practices in Manisa and İzmir provinces. The basic purposes of this research are; to make a comparison between the enterprises apply and do not apply good agricultural practices, to determine the awareness of the producers to good agricultural practices, to specify the tendency of the farmers towards good agricultural practices and to present the factors affecting to good agriculture. In the scope of the study, 25 grape producers in Manisa and 20 mandarin producers in Izmir that apply good agricultural practices have been participated in a survey. Besides, the same survey was also conducted with the same number of producers which do not apply good agricultural practices. To analyze the data, simple calculations such as average, percentage, frequency and through the use of the crosstabs were used and the social-economic status of the producers and some technical and economical specifications of the enterprises were determined. The tendency of the producers towards performing good agricultural practices and the factors affecting to these tendencies have been observed. The tendency of the producers were determined by using Logit Regression Analysis.

HONESTY AND GOOD PRACTICE IN SCIENTIFIC RESEARCH

Directory of Open Access Journals (Sweden)

Jože Trontelj

2008-01-01

Full Text Available In the field of science, we see cases of misconduct ranging from relatively minor departurefrom good manners and practice to more severe dishonesty and even criminal behaviour.Unethical experiments on human beings are among the worst abuses in scientific researchin medicine. Unethical research is usually also worthless from the scientific point of view.The commonest types of offence, however, include mismanagement of data, conscious misinterpretation,wrongful authorship, biased citation of work by others, plagiarism, misquotationor suppression of findings for the interests or upon the request of the sponsor or In the field of science, we see cases of misconduct ranging from relatively minor departurefrom good manners and practice to more severe dishonesty and even criminal behaviour.Unethical experiments on human beings are among the worst abuses in scientific researchin medicine. Unethical research is usually also worthless from the scientific point of view.The commonest types of offence, however, include mismanagement of data, conscious misinterpretation,wrongful authorship, biased citation of work by others, plagiarism, misquotationor suppression of findings for the interests or upon the request of the sponsor or In the field of science, we see cases of misconduct ranging from relatively minor departurefrom good manners and practice to more severe dishonesty and even criminal behaviour.Unethical experiments on human beings are among the worst abuses in scientific researchin medicine. Unethical research is usually also worthless from the scientific point of view.The commonest types of offence, however, include mismanagement of data, conscious misinterpretation,wrongful authorship, biased citation of work by others, plagiarism, misquotationor suppression of findings for the interests or upon the request of the sponsor or even a senior scientist in the team. Every case of misconduct and fraud may causedamage: it may undermine confidence of the

Good Cell Culture Practice for stem cells and stem-cell-derived models.

Science.gov (United States)

Pamies, David; Bal-Price, Anna; Simeonov, Anton; Tagle, Danilo; Allen, Dave; Gerhold, David; Yin, Dezhong; Pistollato, Francesca; Inutsuka, Takashi; Sullivan, Kristie; Stacey, Glyn; Salem, Harry; Leist, Marcel; Daneshian, Mardas; Vemuri, Mohan C; McFarland, Richard; Coecke, Sandra; Fitzpatrick, Suzanne C; Lakshmipathy, Uma; Mack, Amanda; Wang, Wen Bo; Yamazaki, Daiju; Sekino, Yuko; Kanda, Yasunari; Smirnova, Lena; Hartung, Thomas

2017-01-01

The first guidance on Good Cell Culture Practice (GCCP) dates back to 2005. This document expands this to include aspects of quality assurance for in vitro cell culture focusing on the increasingly diverse cell types and culture formats used in research, product development, testing and manufacture of biotechnology products and cell-based medicines. It provides a set of basic principles of best practice that can be used in training new personnel, reviewing and improving local procedures, and helping to assure standard practices and conditions for the comparison of data between laboratories and experimentation performed at different times. This includes recommendations for the documentation and reporting of culture conditions. It is intended as guidance to facilitate the generation of reliable data from cell culture systems, and is not intended to conflict with local or higher level legislation or regulatory requirements. It may not be possible to meet all recommendations in this guidance for practical, legal or other reasons. However, when it is necessary to divert from the principles of GCCP, the risk of decreasing the quality of work and the safety of laboratory staff should be addressed and any conclusions or alternative approaches justified. This workshop report is considered a first step toward a revised GCCP 2.0.

75 FR 80011 - Good Laboratory Practice for Nonclinical Laboratory Studies

Science.gov (United States)

2010-12-21

.... FDA-2010-N-0548] Good Laboratory Practice for Nonclinical Laboratory Studies AGENCY: Food and Drug... (FDA) is seeking comment on whether to amend the regulations governing good laboratory practices (GLPs..., 1978 (43 FR 60013). As stated in its scope (Sec. 58.1), this regulation prescribes good laboratory...

Good practices in Local Government - A first overview of Portuguese reality

Science.gov (United States)

Carvalhosa, P.; Portela, F.; Machado, J.; Santos, M. F.; Abelha, A.

2017-03-01

Good practices in eGov are being increasingly used by Local Governments being that it is considered by them as an advantage. The main goal is providing to the town hall a differentiation point and approximate their services to the citizens. For this, it is necessary to define and apply innovative strategies in order to increase the use of services by the citizens. This paper is framed in a research work and it presents a first overview of the existing good practices in eGov, taking in consideration the Portuguese’s reality. The good practices identified were distinguished with many awards and with a positive response from the target audience. The use of digital marketing strategies aims to increase their membership and coming closer the municipalities of its citizens through the dissemination of the good practices. At this moment the data collected are almost exclusively of good practice in Portugal, however some international practices were also identified. As a result of this study the community has a list of good practices that can be applied in their municipalities.

Emerging Good Practices for Transforming Value Assessment: Patients' Voices, Patients' Values.

Science.gov (United States)

Perfetto, Eleanor M; Harris, Jason; Mullins, C Daniel; dosReis, Susan

2018-04-01

Patient engagement is a transformative strategy for improving value assessment. US value framework developers have increased engagement activities, but more needs to be learned about how to best achieve meaningful patient engagement in value assessment. The objective was to glean good practices in patient engagement emerging from patient community experiences, to be used in value assessment. The National Health Council Value Workgroup conducted a survey and held a focus group with its member advocacy organizations to gather experiences with value framework developers and views on emerging good practices. Ten of 13 organizations completed the survey; reporting 13 interactions with four framework developers. Most rated experiences as "good" to "very good." Emerging good practices included (1) engage early; (2) engage a range of patients; (3) leverage patient-provided information, data resources, and outreach mechanisms; (4) be transparent; and (5) appreciate and accommodate resource constraints. Twelve of 13 organizations participated in the focus group, and this produced 30 emerging good practices in four areas: (1) timing; (2) methodology and data; (3) partnering; and (4) characterizing engagement. Patient engagement was limited in early development of value frameworks but has increased in the past few years. Patient groups report positive experiences that can serve as emerging good practices. These groups also reported experienced challenges in their interactions and recommended good practices to mitigate those challenges. The growing pool of patient engagement experiences can be translated into good practices to advance a patient-centered, value-driven health care ecosystem. Lessons learned from these early experiences can help establish recommend emerging good practices that can eventually result in best practices and standards in the field. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc

75 FR 16345 - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment

Science.gov (United States)

2010-04-01

.... FDA-1999-N-3539] (formerly Docket No. 1999N-4783) Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... Subjects in 21 CFR Part 10 Administrative practice and procedure, News media. 0 Therefore, under the...

Health physics manual of good practices for tritium facilities

Energy Technology Data Exchange (ETDEWEB)

Blauvelt, R.K.; Deaton, M.R.; Gill, J.T. [and others

1991-12-01

The purpose of this document is to provide written guidance defining the generally accepted good practices in use at Department of Energy (DOE) tritium facilities. A {open_quotes}good practice{close_quotes} is an action, policy, or procedure that enhances the radiation protection program at a DOE site. The information selected for inclusion in this document should help readers achieve an understanding of the key radiation protection issues at tritium facilities and provide guidance as to what characterizes excellence from a radiation protection point of view. The ALARA (As Low as Reasonable Achievable) program at DOE sites should be based, in part, on following the good practices that apply to their operations.

Guide to good practice in radiation protection training

International Nuclear Information System (INIS)

Johnson, N.; Schenley, C.; Smith, A.; Weseman, M.

1988-10-01

This set of guidelines applies to radiation protection training programs for all Department of Energy (DOE) contractors, subcontractors, and visitors to DOE contractor facilities. It is to be used as a self-evaluation tool by DOE contractors as they develop and evaluate their training programs. This document is based on good practice guidelines used by a variety of different facilities both within and outside of the DOE contractor system. Good practices are not requirements; they are guidelines that contractors should use as they develop and conduct training programs. The applicability of the contents of the Guide to Good Practice in Radiation Protection Training depends upon each DOE facility's scope and need for radiation safety training. Although the focus of this document is radiation protection training, it is important that the process by which training is developed and implemented be discussed. Therefore, the first section presents guidelines for performance-based training and ideas to be considered regarding the structure and documentation of the training function

External designers in product design processes of small manufacturing firms

NARCIS (Netherlands)

Berends, Hans; Reymen, Isabelle; Stultiëns, Rutger G L; Peutz, Murk

Small manufacturing firms often fail to reap the benefits of good design practices. This study investigates how the involvement of external designers influences the evolution of product design processes in small manufacturing firms. Qualitative and quantitative process research methods were used to

A Framework of Retailer-Manufacturer Cooperation and Coopetition: Consumer Durable Goods Retailers’ Case Studies

Directory of Open Access Journals (Sweden)

Marzanna Katarzyna Witek-Hajduk

2017-03-01

Full Text Available Objective: The purpose of this paper is to develop a framework of cooperation and coopetition between retailers and key manufacturers from a perspective of retailers offering consumer durables. Research Design & Methods: In order to answer the research questions semi-structured, in-depth and face-to-face interviews with managers of six SMEs or large retailers operating in Poland and offering consumer durables were carried out. Findings: The empirical studies confirm both cooperation and coopetition between retailers and manufacturers – suppliers of consumer durables depending on, among others, the category of consumer goods and the balance of power between retailers and manufacturers. The scope of cooperation is not too wide, and concerns only some of the value chain processes indicated in the literature. Implications & Recommendations: Conducted studies are exploratory and need to be deepen with the use of quantitative research that will help determine the impact of the balance of power between manufacturers and retailers and the strength of retailer-manufacturer relations on the range / areas and financial and non-financial performance of this cooperation. Contribution & Value Added: The originality of this work lies in studying some aspects of retailers’ relations with their key suppliers operating in consumer durables market.

Modelling curves of manufacturing feasibilities and demand

Directory of Open Access Journals (Sweden)

Soloninko K.S.

2017-03-01

Full Text Available The authors research the issue of functional properties of curves of manufacturing feasibilities and demand. Settlement of the problem, and its connection with important scientific and practical tasks. According to its nature, the market economy is unstable and is in constant movement. Economy has an effective instrument for explanation of changes in economic environment; this tool is called the modelling of economic processes. The modelling of economic processes depends first and foremost on the building of economic model which is the base for the formalization of economic process, that is, the building of mathematical model. The effective means for formalization of economic process is the creation of the model of hypothetic or imaginary economy. The building of demand model is significant for the market of goods and services. The problem includes the receiving (as the result of modelling definite functional properties of curves of manufacturing feasibilities and demand according to which one can determine their mathematical model. Another problem lies in obtaining majorant properties of curves of joint demand on the market of goods and services. Analysis of the latest researches and publications. Many domestic and foreign scientists dedicated their studies to the researches and building of the models of curves of manufacturing feasibilities and demand. In spite of considerable work of the scientists, such problems as functional properties of the curves and their practical use in modelling. The purpose of the article is to describe functional properties of curves of manufacturing feasibilities and demand on the market of goods and services on the base of modelling of their building. Scientific novelty and practical value. The theoretical regulations (for functional properties of curves of manufacturing feasibilities and demand received as a result of the present research, that is convexity, give extra practical possibilities in a microeconomic

Protection of people and environment from radiation risk through good regulatory practice

Science.gov (United States)

Jais, Azlina Mohammad; Hassan, Najwa

2017-01-01

The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be

Understanding Graduate School Aspirations: The Effect of Good Teaching Practices

Science.gov (United States)

Hanson, Jana M.; Paulsen, Michael B.; Pascarella, Ernest T.

2016-01-01

This study examined the effects of good teaching practices on post-baccalaureate degree aspirations using logistic regression techniques on a multi-institutional, longitudinal sample of students at 4-year colleges and universities in the USA. We examined whether eight good teaching practices (non-classroom interactions with faculty, prompt…

Operational practices of lean manufacturing: Potentiating environmental improvements

Directory of Open Access Journals (Sweden)

Marcos José Alves Pinto Junior

2017-10-01

Full Text Available Purpose: The objective of this paper is to investigate how environmental improvements can be achieved through operational practices of Lean Manufacturing. Design/methodology/approach: A literature review was conducted to analyze the relationship between operational practices of Lean and reduction of environmental impact in organizational contexts. Verified theoretically, this relationship was observed in a company of the electronics industry, through an exploratory research which contemplated a mixed approach. The adopted research method consisted of a single case study, by providing greater depth and detail of the study. Utilized a research protocol, validated test pilot. The instruments for data collection were semi-structured interviews, direct observation and document analysis. The information was examined qualitatively considering the technique for content analysis. Findings: As a result of the study, it was found that there is evidence for the existence of relationship between the practices of Lean, for example, Kaizen, PDCA (plan, do, check, act, Ishikawa Diagram, Poka-Yoke, Standardized Work and Value Stream Mapping, with the reduction of environmental impacts of an organization. This reduction was observed after application of these practices that resulted in the reduction of energy consumption, water and waste generation. These results were accounted for financially, contributing to a reduction of annual costs by about US$ 20,900. Originality/value: The study presents in detail, the application of operational practices of Lean Manufacturing, with an effective view to reducing the environmental impact and cost reduction. The literature review, a detailed description of the application process and financial results are important information that contributes to the scientific studies that address traditional operating practices and the search for better environmental performance.

Operational practices of lean manufacturing: Potentiating environmental improvements

Energy Technology Data Exchange (ETDEWEB)

Pinto, Marcos José Alves Junior; Mendes, Juliana Veiga

2017-07-01

Purpose: The objective of this paper is to investigate how environmental improvements can be achieved through operational practices of Lean Manufacturing. Design/methodology/approach: A literature review was conducted to analyze the relationship between operational practices of Lean and reduction of environmental impact in organizational contexts. Verified theoretically, this relationship was observed in a company of the electronics industry, through an exploratory research which contemplated a mixed approach. The adopted research method consisted of a single case study, by providing greater depth and detail of the study. Utilized a research protocol, validated test pilot. The instruments for data collection were semi-structured interviews, direct observation and document analysis. The information was examined qualitatively considering the technique for content analysis. Findings: As a result of the study, it was found that there is evidence for the existence of relationship between the practices of Lean, for example, Kaizen, PDCA (plan, do, check, act), Ishikawa Diagram, Poka-Yoke, Standardized Work and Value Stream Mapping, with the reduction of environmental impacts of an organization. This reduction was observed after application of these practices that resulted in the reduction of energy consumption, water and waste generation. These results were accounted for financially, contributing to a reduction of annual costs by about US$ 20,900. Originality/value: The study presents in detail, the application of operational practices of Lean Manufacturing, with an effective view to reducing the environmental impact and cost reduction. The literature review, a detailed description of the application process and financial results are important information that contributes to the scientific studies that address traditional operating practices and the search for better environmental performance.

Operational practices of lean manufacturing: Potentiating environmental improvements

International Nuclear Information System (INIS)

Pinto, Marcos José Alves Junior; Mendes, Juliana Veiga

2017-01-01

Purpose: The objective of this paper is to investigate how environmental improvements can be achieved through operational practices of Lean Manufacturing. Design/methodology/approach: A literature review was conducted to analyze the relationship between operational practices of Lean and reduction of environmental impact in organizational contexts. Verified theoretically, this relationship was observed in a company of the electronics industry, through an exploratory research which contemplated a mixed approach. The adopted research method consisted of a single case study, by providing greater depth and detail of the study. Utilized a research protocol, validated test pilot. The instruments for data collection were semi-structured interviews, direct observation and document analysis. The information was examined qualitatively considering the technique for content analysis. Findings: As a result of the study, it was found that there is evidence for the existence of relationship between the practices of Lean, for example, Kaizen, PDCA (plan, do, check, act), Ishikawa Diagram, Poka-Yoke, Standardized Work and Value Stream Mapping, with the reduction of environmental impacts of an organization. This reduction was observed after application of these practices that resulted in the reduction of energy consumption, water and waste generation. These results were accounted for financially, contributing to a reduction of annual costs by about US$ 20,900. Originality/value: The study presents in detail, the application of operational practices of Lean Manufacturing, with an effective view to reducing the environmental impact and cost reduction. The literature review, a detailed description of the application process and financial results are important information that contributes to the scientific studies that address traditional operating practices and the search for better environmental performance.

The influence of lean manufacturing practices in cellular manufacturing qualifying attributes

Directory of Open Access Journals (Sweden)

Giuliano Almeida Marodin

2013-11-01

Full Text Available This article aims to investigate how of lean production (LP influences to a manufacturing cell (MC performance, based on the theoretical study about the attributes that characterize a MC. It was necessary to develop the concept of MC in a socio-technical system perspective, incorporating a technical attribute, a social attribute and the elements of time, space and information to define a "real cell". The results show that most of LM practices aim to increase time and information. The rapid problem solving process and the use of minimal amount of inventory between the activities of the cell seeks to simultaneously reduces the processing time and increase the degree of information. Although influenced to a lesser degree, the organizational attribute and space element are also positively influenced by the practical application of PE.

Clinical audit: Development of the criteria of good practices

International Nuclear Information System (INIS)

Soimakallio, S.; Alanen, A.; Jaervinen, H.; Ahonen, A.; Ceder, K.; Lyyra-Laitinen, T.; Paunio, M.; Sinervo, T.; Wigren, T.

2011-01-01

Clinical audit is a systematic review of the procedures in order to improve the quality and the outcome of patient care, whereby the procedures are examined against agreed standards for good medical Radiological procedures. The criteria of good procedures (i.e. the good practice) are thus the cornerstones for development of clinical audits: these should be the basis of assessments regardless of the type of the audit-external, internal, comprehensive or partial. A lot of criteria for good practices are available through the recommendations and publications by international and national professional societies and other relevant organisations. For practical use in clinical audits, the criteria need to be compiled, sorted out and agreed on for the particular aims of an audit (comprehensive or partial, external or internal). The national professional and scientific societies can provide valuable contribution to this development. For examination-or treatment-specific criteria- preliminary consensus needs to be obtained with the help of clinical experts, while clinical audits can be useful as a benchmarking tool to improve the criteria. (authors)

Evaluation Instruments and Good Practices in Online Education

Science.gov (United States)

Baldwin, Sally J.; Trespalacios, Jesús

2017-01-01

Chickering and Gamson's (1987) "Seven Principles for Good Practice in Undergraduate Education" offers extensively researched and validated tenets for best practices in higher education. After a review of the literature, twenty-eight evaluation instruments currently used to design and review online courses in higher education institutions…

Health physics manual of good practices for tritium facilities

International Nuclear Information System (INIS)

Blauvelt, R.K.; Deaton, M.R.; Gill, J.T.

1991-12-01

The purpose of this document is to provide written guidance defining the generally accepted good practices in use at Department of Energy (DOE) tritium facilities. A open-quotes good practiceclose quotes is an action, policy, or procedure that enhances the radiation protection program at a DOE site. The information selected for inclusion in this document should help readers achieve an understanding of the key radiation protection issues at tritium facilities and provide guidance as to what characterizes excellence from a radiation protection point of view. The ALARA (As Low as Reasonable Achievable) program at DOE sites should be based, in part, on following the good practices that apply to their operations

Behavioral Patterns in Special Education. Good Teaching Practices.

Science.gov (United States)

Rodríguez-Dorta, Manuela; Borges, África

2017-01-01

Providing quality education means to respond to the diversity in the classroom. The teacher is a key figure in responding to the various educational needs presented by students. Specifically, special education professionals are of great importance as they are the ones who lend their support to regular classroom teachers and offer specialized educational assistance to students who require it. Therefore, special education is different from what takes place in the regular classroom, demanding greater commitment by the teacher. There are certain behaviors, considered good teaching practices, which teachers have always been connected with to achieve good teaching and good learning. To ensure that these teachers are carrying out their educational work properly it is necessary to evaluate. This means having appropriate instruments. The Observational Protocol for Teaching Functions in Primary School and Special Education (PROFUNDO-EPE, v.3., in Spanish) allows to capture behaviors from these professionals and behavioral patterns that correspond to good teaching practices. This study evaluates the behavior of two special education teachers who work with students from different educational stages and educational needs. It reveals that the analyzed teachers adapt their behavior according the needs and characteristics of their students to the students responding more adequately to the needs presented by the students and showing good teaching practices. The patterns obtained indicate that they offer support, help and clear guidelines to perform the tasks. They motivate them toward learning by providing positive feedback and they check that students have properly assimilated the contents through questions or non-verbal supervision. Also, they provide a safe and reliable climate for learning.

Impact of TQM practices on innnovation performance among manufacturing companies in Malaysia

Directory of Open Access Journals (Sweden)

Choi Sang Long

2015-05-01

Full Text Available This study examines the impact of total quality management (TQM practices on an organisation’s innovation performance. Correlation coefficient and regression analysis is used to examine the relationship between TQM practices and innovation performance. This study’s sample is drawn from the manufacturing organisations located in the district of Rawang in the state of Selangor, Malaysia. The empirical results of this study confirm that TQM has a positive impact on innovation performance across five measured practices: customer focus, leadership, process management, strategic planning, and people management. Furthermore, the three most influential TQM practices are identfied as people management,process management, and customer focus. Managers in the manufacturing sector can find this study useful, especially if they are aiming to improve their organisation’s innovation performance with the help of quality management practices.

Pharmacokinetic studies of neuromuscular blocking agents: Good Clinical Research Practice (GCRP)

DEFF Research Database (Denmark)

Viby-Mogensen, J.; Østergaard, D.; Donati, F.

2000-01-01

Good Clinical Research Practice (GCRP), neuromuscular blocking agents, pharmacokinetics, pharmacokinetic/pharmacodynamic modeling, population pharmacokinetics, statistics, study design......Good Clinical Research Practice (GCRP), neuromuscular blocking agents, pharmacokinetics, pharmacokinetic/pharmacodynamic modeling, population pharmacokinetics, statistics, study design...

The Highest Good and the Practical Regulative Knowledge in Kant’s Critique of Practical Reason

OpenAIRE

Joel Thiago Klein

2016-01-01

In this paper I defend three different points: first, that the concept of highest good is derived from an a priori but subjective argument, namely a maxim of pure practical reason; secondly, that the theory regarding the highest good has the validity of a practical regulative knowledge; and thirdly, that the practical regulative knowledge can be understood as the same “holding something to be true” as Kant attributes to hope and believe.

Good Practices in Free-energy Calculations

Science.gov (United States)

Pohorille, Andrew; Jarzynski, Christopher; Chipot, Christopher

2013-01-01

As access to computational resources continues to increase, free-energy calculations have emerged as a powerful tool that can play a predictive role in drug design. Yet, in a number of instances, the reliability of these calculations can be improved significantly if a number of precepts, or good practices are followed. For the most part, the theory upon which these good practices rely has been known for many years, but often overlooked, or simply ignored. In other cases, the theoretical developments are too recent for their potential to be fully grasped and merged into popular platforms for the computation of free-energy differences. The current best practices for carrying out free-energy calculations will be reviewed demonstrating that, at little to no additional cost, free-energy estimates could be markedly improved and bounded by meaningful error estimates. In energy perturbation and nonequilibrium work methods, monitoring the probability distributions that underlie the transformation between the states of interest, performing the calculation bidirectionally, stratifying the reaction pathway and choosing the most appropriate paradigms and algorithms for transforming between states offer significant gains in both accuracy and precision. In thermodynamic integration and probability distribution (histogramming) methods, properly designed adaptive techniques yield nearly uniform sampling of the relevant degrees of freedom and, by doing so, could markedly improve efficiency and accuracy of free energy calculations without incurring any additional computational expense.

78 FR 16824 - Tobacco Product Manufacturing Practice; Establishment of a Public Docket

Science.gov (United States)

2013-03-19

... manufacturing operations. DATES: Submit electronic or written comments on the tobacco companies' recommendations... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2013-N-0227] Tobacco Product Manufacturing Practice; Establishment of a Public Docket AGENCY: Food...

European good practice in composite floor construction

NARCIS (Netherlands)

Brekelmans, J.W.P.M.; Daniels, B.J.; Stark, J.W.B.; Darwin, David; Buckner, C.D.

1992-01-01

Previous European experience, research and design for composite slabs with profiled steel decking are discussed. Present efforts to harmonize composite slab design and good construction practice are presented. Future European developments, for the next five years, are postulated.

76 FR 82308 - Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers...

Science.gov (United States)

2011-12-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0659... that performs a manufacturing step and is responsible for complying with CGTP requirements. The... dated January 2009. DATES: Submit either electronic or written comments on Agency guidances at any time...

Good Practice Standards – a Regulation Tool

DEFF Research Database (Denmark)

Sørensen, Marie Jull

2013-01-01

The purpose of this article is to identify the considerations weighed in regulation with good practice standards. In this article, potential due process problems with regulation via legal standards are identified and compared to other considerations, which this regulation technique meets....

Wind Farms Community Engagement Good Practice Review

DEFF Research Database (Denmark)

Aitken, Mhairi; Haggett, Claire; Rudolph, David Philipp

2014-01-01

This report sets out the findings of a review of community engagement for wind farm developments. We focus in particular on the engagement carried out by developers with communities. The aims of the study were to evaluate current good practice for engaging people in decision making about on......- and offshore wind farms in different European countries; to evaluate the effect that different practices have on public opinion and acceptance; and to make relevant recommendations for Scottish policy and planning....

Sociocultural Transformation & Development. Good Practices or Successful Actions

Directory of Open Access Journals (Sweden)

Oriol Ríos

2013-10-01

Full Text Available The most disadvantadged neighborhoods in Europe have received funds from State Administration to eradicate social exclusion and overcome processes of urban ghettoization. These processes are being implemented in several social areas such as housing, employment, and education. Actions, defined as "good practices", are usually valued by the quantity and type and not by the quality and final outcomes they achieve. For example, when they improve the living conditions of the populations in these areas. The INCLUD-ED project shows positive results by replacing these "good practices" by "successful actions". They are grounded on scientific evidence in order to respond to the aims set by the neighbours of these disadvantaged neighborhoods.

Manufacturing technology for practical Josephson voltage normals; Fertigungstechnologie fuer praxistaugliche Josephson-Spannungsnormale

Energy Technology Data Exchange (ETDEWEB)

Kohlmann, Johannes; Kieler, Oliver [Physikalisch-Technische Bundesanstalt (PTB), Braunschweig (Germany). Arbeitsgruppe 2.43 ' ' Josephson-Schaltungen' '

2016-09-15

In this contribution we present the manufacturing technology for the fabrication of integrated superconducting Josephson serial circuits for voltage normals. First we summarize some foundations for Josephson voltage normals and sketch the concept and the setup of the circuits, before we describe the manufacturing technology form modern practical Josephson voltage normals.

Alternative Pathways to Apprenticeships. Good Practice Guide

Science.gov (United States)

National Centre for Vocational Education Research (NCVER), 2015

2015-01-01

Apprenticeships are changing. The increasing proportions of people entering apprenticeships at various levels of ability and backgrounds are stimulating demand for alternative pathways to completions. This good practice guide assembles the key findings for education practitioners and workplace supervisors from three related research reports on…

Micro-manufacturing technologies and their applications a theoretical and practical guide

CERN Document Server

Shipley, David

2017-01-01

This book provides in-depth theoretical and practical information on recent advances in micro-manufacturing technologies and processes, covering such topics as micro-injection moulding, micro-cutting, micro-EDM, micro-assembly, micro-additive manufacturing, moulded interconnected devices, and microscale metrology. It is designed to provide complementary material for the related e-learning platform on micro-manufacturing developed within the framework of the Leonardo da Vinci project 2013-3748/542424: MIMAN-T: Micro-Manufacturing Training System for SMEs. The book is mainly addressed to technicians and prospective professionals in the sector and will serve as an easily usable tool to facilitate the translation of micro-manufacturing technologies into tangible industrial benefits. Numerous examples are included to assist readers in learning and implementing the described technologies. In addition, an individual chapter is devoted to technological foresight, addressing market analysis and business models for mic...

Modeling study of air pollution due to the manufacture of export goods in China's Pearl River Delta.

Science.gov (United States)

Streets, David G; Yu, Carolyne; Bergin, Michael H; Wang, Xuemei; Carmichael, Gregory R

2006-04-01

The Pearl River Delta is a major manufacturing region on the south coast of China that produces more than dollar 100 billion of goods annually for export to North America, Europe, and other parts of Asia. Considerable air pollution is caused by the manufacturing industries themselves and by the power plants, trucks, and ships that support them. We estimate that 10-40% of emissions of primary SO2, NO(x), RSP, and VOC in the region are caused by export-related activities. Using the STEM-2K1 atmospheric transport model, we estimate that these emissions contribute 5-30% of the ambient concentrations of SO2, NO(x), NO(z), and VOC in the region. One reason that the exported goods are cheap and therefore attractive to consumers in developed countries is that emission controls are lacking or of low performance. We estimate that state-of-the-art controls could be installed at an annualized cost of dollar 0.3-3 billion, representing 0.3-3% of the value of the goods produced. We conclude that mitigation measures could be adopted without seriously affecting the prices of exported goods and would achieve considerable human health and other benefits in the form of reduced air pollutant concentrations in densely populated urban areas.

Good practice guide for ESP-r developers

NARCIS (Netherlands)

Hensen, J.L.M.

1991-01-01

This report sets out to be a ‘good practice guide’ for researchers involved in the development of the ESP-r building and plant simulation environment, as this is currently under development at various research centres throughout Europe. After an introduction to the background for this work, the

21 CFR 111.355 - What are the design requirements for manufacturing operations?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What are the design requirements for manufacturing operations? 111.355 Section 111.355 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

International standards’ influence in brazilian milk production: a critical perspective about the good manufacturing practices for family farms in the Amazon region

Directory of Open Access Journals (Sweden)

Cristiane Fonseca Costa Corrêa

2016-04-01

Full Text Available Structural changes imposed on Brazil’s dairy industry are influenced by the international market while it presses local industries and local producers. One of the main difficulties in the dairy sector is the standardization of milk based on the international standards of quality. So, to meet these requirements, standard operating procedures are established for the entire production chain, and they’re called '' Good dairy farming practices”. This paper addresses in a systemic way the influences of these standards in the Brazilian milk production, and the difficulties for adopting these procedure standards in family farming, especially in the Amazon region. The Amazonian family farmer is characterized by a peculiar diversity related to the ways they produce and live in society. In addition, there is at the same time a variety of local contexts very striking in the Amazon, which involve and influence the practices of farmers, making it difficult to join a homogenizing principle of good practices. The criticism of this paper does not report the need for sanitation improvements in milk production practices, but it wants to demonstrate as a leading line that the local context and the logic of producers are extremely necessary, so that the actions elaborated can value their practices and have them as a starting point. It should be noted in this study that the result of standard procedures for family farmers is the differentiation and social reunification in between them, where some are consolidated in milk production and others are excluded.

Microstructure-Based Counterfeit Detection in Metal Part Manufacturing

Science.gov (United States)

Dachowicz, Adam; Chaduvula, Siva Chaitanya; Atallah, Mikhail; Panchal, Jitesh H.

2017-11-01

Counterfeiting in metal part manufacturing has become a major global concern. Although significant effort has been made in detecting the implementation of such counterfeits, modern approaches suffer from high expense during production, invasiveness during manufacture, and unreliability in practice if parts are damaged during use. In this paper, a practical microstructure-based counterfeit detection methodology is proposed, which draws on inherent randomness present in the microstructure as a result of the manufacturing process. An optical Physically Unclonable Function (PUF) protocol is developed which takes a micrograph as input and outputs a compact, unique string representation of the micrograph. The uniqueness of the outputs and their robustness to moderate wear and tear is demonstrated by application of the methodology to brass samples. The protocol is shown to have good discriminatory power even between samples manufactured in the same batch, and runs on the order of several seconds per part on inexpensive machines.

Health physics manual of good practices for accelerator facilities

International Nuclear Information System (INIS)

Casey, W.R.; Miller, A.J.; McCaslin, J.B.; Coulson, L.V.

1988-04-01

It is hoped that this manual will serve both as a teaching aid as well as a useful adjunct for program development. In the context of application, this manual addresses good practices that should be observed by management, staff, and designers since the achievement of a good radiation program indeed involves a combined effort. Ultimately, radiation safety and good work practices become the personal responsibility of the individual. The practices presented in this manual are not to be construed as mandatory rather they are to be used as appropriate for the specific case in the interest of radiation safety. As experience is accrued and new data obtained in the application of this document, ONS will update the guidance to assure that at any given time the guidance reflects optimum performance consistent with current technology and practice.The intent of this guide therefore is to: define common health physics problems at accelerators; recommend suitable methods of identifying, evaluating, and managing accelerator health physics problems; set out the established safety practices at DOE accelerators that have been arrived at by consensus and, where consensus has not yet been reached, give examples of safe practices; introduce the technical literature in the accelerator health physics field; and supplement the regulatory documents listed in Appendix D. Many accelerator health physics problems are no different than those at other kinds of facilities, e.g., ALARA philosophy, instrument calibration, etc. These problems are touched on very lightly or not at all. Similarly, this document does not cover other hazards such as electrical shock, toxic materials, etc. This does not in any way imply that these problems are not serious. 160 refs

Microbiological analysis and evaluation of Good Manufacturing Practices during the processing of raw white cabbage (Brassica oleracea var. capitata f. alba served in a self-service restaurant

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Jhonathan Campos do Couto Beltrão

2017-11-01

Full Text Available Introduction: The consumption of meals outside the home has become an increasingly common practice in the life of the Brazilian population and of everyone. Objective: The aim of this work was to evaluate the microbiological quality of raw white cabbage (Brassica oleracea var. capitata f. alba, served in an institutional self-service restaurant, in the different stages of processing (reception, sanitation, slicing, cooling and distribution. In addition, Good Manufacturing Practices (GMP were evaluated through a checklist. Method: Total coliform, Escherichia coli and total aerobic bacteria were counted and Salmonella spp. was searched. Results: A sample collected at the reception stage showed Salmonella spp. Sanitization eliminated Salmonella spp. and reduced total coliforms and E. coli to undetectable numbers. The environment, the equipment and the manipulation strongly influenced the microbiological quality of food. Samples collected on day 4, after slicing, showed 3.2 log CFU of E. coli per g and at distribution 4.1 log CFU/g, which indicates unsatisfactory hygienic conditions. The restaurant had 55.75% compliance with GMP items, being classified as regular (Group 2, in accordance with RDC n° 275/2002. Conclusions: The non-conformities (37.00% observed in the exposure to prepared food consumption may be influencing the microbiological quality of raw white cabbage salad served. In this way we highlight the importance of the application of GMP in the production process to obtain a safe food and the compliance with the four POP required by RDC n° 216/2004.

Good enough practices in scientific computing.

Science.gov (United States)

Wilson, Greg; Bryan, Jennifer; Cranston, Karen; Kitzes, Justin; Nederbragt, Lex; Teal, Tracy K

2017-06-01

Computers are now essential in all branches of science, but most researchers are never taught the equivalent of basic lab skills for research computing. As a result, data can get lost, analyses can take much longer than necessary, and researchers are limited in how effectively they can work with software and data. Computing workflows need to follow the same practices as lab projects and notebooks, with organized data, documented steps, and the project structured for reproducibility, but researchers new to computing often don't know where to start. This paper presents a set of good computing practices that every researcher can adopt, regardless of their current level of computational skill. These practices, which encompass data management, programming, collaborating with colleagues, organizing projects, tracking work, and writing manuscripts, are drawn from a wide variety of published sources from our daily lives and from our work with volunteer organizations that have delivered workshops to over 11,000 people since 2010.

Use of digital technologies for nasal prosthesis manufacturing.

Science.gov (United States)

Palousek, David; Rosicky, Jiri; Koutny, Daniel

2014-04-01

Digital technology is becoming more accessible for common use in medical applications; however, their expansion in prosthetic and orthotic laboratories is not large because of the persistent image of difficult applicability to real patients. This article aims to offer real example in the area of human facial prostheses. This article describes the utilization of optical digitization, computational modelling, rapid prototyping, mould fabrication and manufacturing of a nasal silicone prosthesis. This technical note defines the key points of the methodology and aspires to contribute to the introduction of a certified manufacturing procedure. The results show that the used technologies reduce the manufacturing time, reflect patient's requirements and allow the manufacture of high-quality prostheses for missing facial asymmetric parts. The methodology provides a good position for further development issues and is usable for clinical practice. Clinical relevance Utilization of digital technologies in facial prosthesis manufacturing process can be a good contribution for higher patient comfort and higher production efficiency but with higher initial investment and demands for experience with software tools.

Tourism. Leonardo da Vinci Series: Good Practices.

Science.gov (United States)

Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

This brochure, part of a series about good practices in vocational training in the European Union, describes 10 projects that have promoted investment in human resources through training in the tourism sector to promote sustainable, or responsible, tourism. The projects and their countries of origin are as follows: (1) BEEFT, training of mobility…

Standard practice for manufacturing characterization of digital detector arrays

CERN Document Server

American Society for Testing and Materials. Philadelphia

2007-01-01

1.1 This practice describes the evaluation of Digital Detector Arrays (DDAs), and assures that one common standard exists for quantitative comparison of DDAs so that an appropriate DDA is selected to meet NDT requirements. 1.2 This practice is intended for use by manufacturers or integrators of DDAs to provide quantitative results of DDA characteristics for NDT user or purchaser consumption. Some of these tests require specialized test phantoms to assure consistency among results among suppliers or manufacturers. These tests are not intended for users to complete, nor are they intended for long term stability tracking and lifetime measurements. However, they may be used for this purpose, if so desired. 1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropr...

Aplicação do sistema de gestão da qualidade BPF (boas práticas de fabricação na indústria de produtos farmacêuticos veterinários The usage of the GMP (good manufacturing practices quality management system for veterinary pharmaceutical industries

Directory of Open Access Journals (Sweden)

Felipe Araújo Calarge

2007-01-01

veterinary products in Brazil. This article intends to depict the main aspects and results which come from a survey research, which tried to analyze how veterinary product manufacturers have been adapted to the usage of Good Manufacturing Practices as a system of quality control and management. Due to collecting a bibliography, aspects relating to the context of agribusiness competitiveness and the market of veterinary products are described, as well as the main topics relating to standard procedures emphasized in Good Manufacturing Practices. The study was carried out as a survey in companies manufacturing veterinary products, attempting to characterize the methodology of the adopted research, as well as to report and analyze the collected data. The study concludes, among other aspects, that veterinary product manufacturers have been implementing Good Manufacturing Practices which are more encouraged by aspects which come from a more efficient management of their productive resources than by complying with governmental standards and legislations.

78 FR 64735 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Science.gov (United States)

2013-10-29

..., chemical, physical, or radiological contaminates of the food that can cause animal or human health concerns.... The contaminants addressed by the FCP can be hazardous to livestock health and production, pet health... health organizations, and pet food manufacturers, to issue new regulations establishing, among other...

Safety standards, legislation and codes of practice for fuel cell manufacture and operation

Energy Technology Data Exchange (ETDEWEB)

Wilcox, C.P.

1999-07-01

This report examines safety standards, legislation and codes of practice for fuel cell manufacture and operation in the UK, Europe and internationally. Management of health and safety in the UK is discussed, and the characteristics of phosphoric acid (PAFC), proton exchange membrane (PEM), molten carbonate (MCFC), solid oxide (SOFC) fuel cells are described. Fuel cell power plant standards and manufacture in the UK, design and operational considerations, end of life disposal, automotive fuel cell system, and fuelling and vehicular concerns are explored, and standards, legislation and codes of practice are explained in the appendix.

Good Policy, Good Practice II. Improving Outcomes and Productivity in Higher Education: A Guide for Policymakers

Science.gov (United States)

Brenneman, Meghan Wilson; Callan, Patrick M.; Ewell, Peter T.; Finney, Joni E.; Jones, Dennis P.; Zis, Stacey

2010-01-01

This new edition of "Good Policy, Good Practice II" revises and updates the authors' 2007 publication. Like the earlier edition, it responds to one of the questions that is raised most frequently in the authors' work with public policy and education leaders as they begin to address the national and state imperatives to increase the proportion of…

[Identification of Good-Practice Projects in Promoting Physical Activity - Methods, Pitfalls and Sampled Outcomes].

Science.gov (United States)

Henn, Annette; Karger, Claudia; Wöhlken, Katrin; Meier, Diana; Ungerer-Röhrich, Ulrike; Graf, Christine; Woll, Alexander

2017-03-01

The aim of this paper is to identify and show examples of good practice of public health promotion. For this, uniform quality criteria were worked out under consideration of national and international scientific literature.For the identification of examples of good practice, a comparison of different quality criteria was carried out and combined with each other in a first step. In the following step, examples of good practice were identified after a comprehensive search. The choice of the "good-practice" projects is exemplary and lays no claim to completeness.6 main quality criteria (QC) of programs promoting physical activity could be identified in the national and international context. The analysis showed altogether 10 projects which can exemplarily be classified as examples of good practice of the target groups of children and teenagers, adults, older people and people with pre-existing illnesses. These projects, however, show major differences in their (methodological) quality.The analysis reports a lack of "Good-Practice" examples. Deficits lie mainly in documentation and sustainability. Because of incomplete documentation, an assessment as a "Good-Practice" example is only possible to a limited extent; a lot of information, particularly in the evaluation, is missing. © Georg Thieme Verlag KG Stuttgart · New York.

Principles of Good Practice in SoTL

Science.gov (United States)

Felten, Peter

2013-01-01

For the Scholarship of Teaching and Learning (SoTL) to be understood as significant intellectual work in the academy, SoTL practitioners need to identify shared principles of good practice. While honoring the diversity of SoTL in its many forms across the globe, such principles can serve as a heuristic for assessing work in our field. These…

Microbiological quality control practices at Australian Radioisotopes

International Nuclear Information System (INIS)

Saunders, M.

1987-01-01

As a domestic manufacturer of therapeutic substances, Australian Radioisotopes (ARI) must adhere to guidelines set out by the Commonwealth Department of Health in the Code of Good Manufacturing Practices for Therapeutic Goods 1983 (GMP). The GMP gives guidelines for staff training, building requirements, sanitation, documentation and quality control practices. These guidelines form the basis for regular audits performed by officers of the National Biological Standards Laboratories. At Lucas Heights, ARI has combined the principles of the GMP with the overriding precautions introduced for environmental and staff safety and protection. Its policy is to maintain a high level of quality assurance for product identity, purity and sterility and apyrogenicity during all stages of product manufacture

The online good practice guide on job finding

DEFF Research Database (Denmark)

Levinsen, Karin Tweddell; Ørngreen, Rikke; Andreasen, Lars Birch

2010-01-01

The Online Good Practice Guide on Job Finding is a result of the project L@JOST, 'Learn about finding jobs through digital storytelling', with the purpose of enhancing the employability possibilities of graduated students through the use of e-portfolio and digital storytelling....

Investigating School-Wide Antecedents of Good Practice Dissemination from Individual Subject Projects

Science.gov (United States)

Christophersen, Knut-Andreas; Elstad, Eyvind; Turmo, Are

2012-01-01

Good practice dissemination is an unsolved problem in education. This article describes how clear and "soft" leadership and perceptions of social and economic exchange operate in the bottom-up processes of school reforms and examines the relative impact of these factors on school-wide good practice dissemination and discusses how…

The Conditional Nature of High Impact/Good Practices on Student Learning Outcomes

Science.gov (United States)

Seifert, Tricia A.; Gillig, Benjamin; Hanson, Jana M.; Pascarella, Ernest T.; Blaich, Charles F.

2014-01-01

Using a multi-institutional sample of undergraduate students, this study found that the relationships between engaging in high impact/good practices and liberal arts outcomes differ based on students' precollege and background characteristics. Findings suggest that high impact/good practices are not a panacea and require a greater degree of…

Single-use disposable technologies for biopharmaceutical manufacturing.

Science.gov (United States)

Shukla, Abhinav A; Gottschalk, Uwe

2013-03-01

The manufacture of protein biopharmaceuticals is conducted under current good manufacturing practice (cGMP) and involves multiple unit operations for upstream production and downstream purification. Until recently, production facilities relied on the use of relatively inflexible, hard-piped equipment including large stainless steel bioreactors and tanks to hold product intermediates and buffers. However, there is an increasing trend towards the adoption of single-use technologies across the manufacturing process. Technical advances have now made an end-to-end single-use manufacturing facility possible, but several aspects of single-use technology require further improvement and are continually evolving. This article provides a perspective on the current state-of-the-art in single-use technologies and highlights trends that will improve performance and increase the market penetration of disposable manufacturing in the future. Copyright © 2012 Elsevier Ltd. All rights reserved.

Management Documentation: Indicators & Good Practice at Cultural Heritage Places

Science.gov (United States)

Eppich, R.; Garcia Grinda, J. L.

2015-08-01

Documentation for cultural heritage places usually refers to describing the physical attributes, surrounding context, condition or environment; most of the time with images, graphics, maps or digital 3D models in their various forms with supporting textural information. Just as important as this type of information is the documentation of managerial attributes. How do managers of cultural heritage places collect information related to financial or economic well-being? How are data collected over time measured, and what are significant indicators for improvement? What quality of indicator is good enough? Good management of cultural heritage places is essential for conservation longevity, preservation of values and enjoyment by the public. But how is management documented? The paper will describe the research methodology, selection and description of attributes or indicators related to good management practice. It will describe the criteria for indicator selection and why they are important, how and when they are collected, by whom, and the difficulties in obtaining this information. As importantly it will describe how this type of documentation directly contributes to improving conservation practice. Good practice summaries will be presented that highlight this type of documentation including Pamplona and Ávila, Spain and Valletta, Malta. Conclusions are drawn with preliminary recommendations for improvement of this important aspect of documentation. Documentation of this nature is not typical and presents a unique challenge to collect, measure and communicate easily. However, it is an essential category that is often ignored yet absolutely essential in order to conserve cultural heritage places.

78 FR 53151 - The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and...

Science.gov (United States)

2013-08-28

...] The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers... availability of the draft guidance entitled ``The Applicability of Good Laboratory Practice in Premarket Device... applicability of good laboratory practice (GLP) to nonclinical laboratory studies conducted in support of...

Implementation of good manufacturing practices (GMP) on human blood irradiation

International Nuclear Information System (INIS)

Boghi, Claudio; Napolitano, Celia M.; Ferreira, Danilo C.; Rela, Paulo Roberto; Zarate, Herman S.

2007-01-01

The irradiation of human blood is used to avoid the TA-GVHD (transfusion-associated graft-versus-host-disease), a rare but devastating adverse effect of leukocytes present in blood components for a immuno-competent transfusion recipients. Usually this irradiation practice is performed to a physical elimination of lymphocytes. The implementation of the GMP will assure that the properly dose in a range of 25 Gy to 50 Gy will be delivered to the blood in the bag collected in a blood tissue bank. The studies to establish the GMP were developed under the guidelines of the standard ISO 11137 - Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization. In this work, two dosimetric systems were used for dose mapping during the studies of irradiator qualification, loading pattern, irradiation process validation and auditing. The CaSO 4 : Dy dosimeter presented difficulties concerning to uncertainty on dose measurement, stability, trace ability and calibration system. The PMMA and gafchromic dosimetric systems have shown a better performance and were adopted on establishment of GMP procedures. The irradiation tests have been done using a Gammacell 220 Irradiator. The developed GMP can be adapted for different types of gamma irradiators, allowing to set up a quality assurance program for blood irradiation. (author)

Implementation of good manufacturing practices (GMP) on human blood irradiation

Energy Technology Data Exchange (ETDEWEB)

Boghi, Claudio; Napolitano, Celia M.; Ferreira, Danilo C.; Rela, Paulo Roberto [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)]. E-mails: cboghi@uol.com.br; cmnapoli@ipen.br; dancarde@ig.com.br; prela@ipen.br; Zarate, Herman S. [Comission Chilena de Energia Nuclear, Santiago (Chile)]. E-mail: hzarate@cchen.cl

2007-07-01

The irradiation of human blood is used to avoid the TA-GVHD (transfusion-associated graft-versus-host-disease), a rare but devastating adverse effect of leukocytes present in blood components for a immuno-competent transfusion recipients. Usually this irradiation practice is performed to a physical elimination of lymphocytes. The implementation of the GMP will assure that the properly dose in a range of 25 Gy to 50 Gy will be delivered to the blood in the bag collected in a blood tissue bank. The studies to establish the GMP were developed under the guidelines of the standard ISO 11137 - Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization. In this work, two dosimetric systems were used for dose mapping during the studies of irradiator qualification, loading pattern, irradiation process validation and auditing. The CaSO{sub 4}: Dy dosimeter presented difficulties concerning to uncertainty on dose measurement, stability, trace ability and calibration system. The PMMA and gafchromic dosimetric systems have shown a better performance and were adopted on establishment of GMP procedures. The irradiation tests have been done using a Gammacell 220 Irradiator. The developed GMP can be adapted for different types of gamma irradiators, allowing to set up a quality assurance program for blood irradiation. (author)

Good manufacturing practices (GMP utilized on human blood irradiation process

Directory of Open Access Journals (Sweden)

Cláudio Boghi

2008-01-01

Full Text Available Irradiation of human blood is used to avoid the TA-GVHD (transfusion-associated graft-versus-host-disease, a rare but devastating adverse effect of leukocytes present in blood components for immunocompetent transfusion recipients. Usually this irradiation practice is performed to a physical elimination of lymphocytes. The implementation of the GMP will assure that the properly dose in a range of 25Gy to 50Gy will be delivered to the blood in the bag collected in a blood tissue bank. The studies to establish the GMP were developed under the guidelines of the standard ISO 11137 - Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization. In this work, two dosimetric systems were used for dose mapping during the studies of irradiator qualification, loading pattern, irradiation process validation and auditing. The CaSO4: Dy dosimeter presented difficulties concerning to uncertainty on dose measurement, stability, trace ability and calibration system. The PMMA and gafchromic dosimetric systems have shown a better performance and were adopted on establishment of GMP procedures. The irradiation tests have been done using a Gammacell 220 Irradiator. The developed GMP can be adapted for different types of gamma irradiators, allowing to set up a quality assurance program for blood irradiation.

Using structural equation modelling to integrate human resources with internal practices for lean manufacturing implementation

Directory of Open Access Journals (Sweden)

Protik Basu

2018-01-01

Full Text Available The purpose of this paper is to explore and integrate the role of human resources with the internal practices of the Indian manufacturing industries towards successful implementation of lean manu-facturing (LM. An extensive literature survey is carried out. An attempt is made to build an ex-haustive list of all the input manifests related to human resources and internal practices necessary for LM implementation, coupled with a similar exhaustive list of the benefits accrued from its suc-cessful implementation. A structural model is thus conceptualized, which is empirically validated based on the data from the Indian manufacturing sector. Hardly any survey based empirical study in India has been found to integrate human resources with the internal processes towards success-ful LM implementation. This empirical research is thus carried out in the Indian manufacturing in-dustries. The analysis reveals six key input constructs and three output constructs, indicating that these constructs should act in unison to maximize the benefits of implementing lean. The structural model presented in this paper may be treated as a guide to integrate human resources with internal practices to successfully implement lean, leading to an optimum utilization of resources. This work is one of the very first researches to have a survey-based empirical analysis of the role of human resources and internal practices of the Indian manufacturing sector towards an effective lean im-plementation.

Connected Cities : Guide to good practice underground space

NARCIS (Netherlands)

Van der Hoeven, F.D.; Hobma, W.

2007-01-01

This guide to good practice underground space is developed within the framework of the EU-funded INTERREG IIIC project ‘Connected Cities’. It focuses on how a strategic use of underground space can facilitate sustainable modes of transportation and mobility in urban and rural areas. Twelve strategic

"Inclusive Working Life" in Norway--experience from "Models of Good Practice" enterprises.

Science.gov (United States)

Lie, Arve

2008-08-01

To determine whether enterprises belonging to the Bank of Models of Good Practice were more successful than average Norwegian enterprises in the reduction of sickness absence, promotion of early return to work, and prevention of early retirement. In 2004 we selected 86 enterprises with a total of approximately 90000 employees from the Inclusive Working Life (IWL) Bank of Models of Good Practice. One representative of workers and one of management from each enterprise received a questionnaire on the aims, organization, and the results of the IWL program by mail. Data on sickness absence, use of early retirement, and disability retirement in the 2000-2004 period were collected from the National Insurance Registry. Data on comparable enterprises were obtained from the National Bureau of Statistics. The response rate was 65%. Although the IWL campaign was directed at reducing sickness absence, preventing early retirement, and promoting employment of the functionally impaired, most attention was paid to reducing sickness absence. Sickness absence rate in Models of Good Practice enterprises (8.2%) was higher than in comparable enterprises that were not part of the Models of Good Practice (6.9%). Implementation of many IWL activities, empowerment and involvement of employees, and good cooperation with the occupational health service were associated with a lower rate of sickness absence. On average, 0.7% new employees per year received disability pension, which is a significantly lower percentage than expected on the basis of the rate of 1.3% per year in comparable enterprises. Frequent use of disability pensioning was associated with high rate of sickness absence and having many employees older than 50 years. On average, 0.4% employees per year received early retirement compensation, which was expected on the basis of national estimates. Frequent use of early retirement was associated with having many employees older than 50 years. Models of Good Practice enterprises had

Good practices for quantitative bias analysis.

Science.gov (United States)

Lash, Timothy L; Fox, Matthew P; MacLehose, Richard F; Maldonado, George; McCandless, Lawrence C; Greenland, Sander

2014-12-01

Quantitative bias analysis serves several objectives in epidemiological research. First, it provides a quantitative estimate of the direction, magnitude and uncertainty arising from systematic errors. Second, the acts of identifying sources of systematic error, writing down models to quantify them, assigning values to the bias parameters and interpreting the results combat the human tendency towards overconfidence in research results, syntheses and critiques and the inferences that rest upon them. Finally, by suggesting aspects that dominate uncertainty in a particular research result or topic area, bias analysis can guide efficient allocation of sparse research resources. The fundamental methods of bias analyses have been known for decades, and there have been calls for more widespread use for nearly as long. There was a time when some believed that bias analyses were rarely undertaken because the methods were not widely known and because automated computing tools were not readily available to implement the methods. These shortcomings have been largely resolved. We must, therefore, contemplate other barriers to implementation. One possibility is that practitioners avoid the analyses because they lack confidence in the practice of bias analysis. The purpose of this paper is therefore to describe what we view as good practices for applying quantitative bias analysis to epidemiological data, directed towards those familiar with the methods. We focus on answering questions often posed to those of us who advocate incorporation of bias analysis methods into teaching and research. These include the following. When is bias analysis practical and productive? How does one select the biases that ought to be addressed? How does one select a method to model biases? How does one assign values to the parameters of a bias model? How does one present and interpret a bias analysis?. We hope that our guide to good practices for conducting and presenting bias analyses will encourage

Top 10 metrics for life science software good practices [version 1; referees: 2 approved

Directory of Open Access Journals (Sweden)

Haydee Artaza

2016-08-01

Full Text Available Metrics for assessing adoption of good development practices are a useful way to ensure that software is sustainable, reusable and functional. Sustainability means that the software used today will be available - and continue to be improved and supported - in the future. We report here an initial set of metrics that measure good practices in software development. This initiative differs from previously developed efforts in being a community-driven grassroots approach where experts from different organisations propose good software practices that have reasonable potential to be adopted by the communities they represent. We not only focus our efforts on understanding and prioritising good practices, we assess their feasibility for implementation and publish them here.

A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice

Directory of Open Access Journals (Sweden)

Gola Mauro

2009-09-01

Full Text Available Abstract Background Main scope of the EU and FDA regulations is to establish a classification criterion for advanced therapy medicinal products (ATMP. Regulations require that ATMPs must be prepared under good manufacturing practice (GMP. We have validated a commercial system for the determination of bacterial endotoxins in compliance with EU Pharmacopoeia 2.6.14, the sterility testing in compliance with EU Pharmacopoeia 2.6.1 and a potency assay in an ATMP constituted of mononucleated cells used in cardiac regeneration. Methods For the potency assay, cells were placed in the upper part of a modified Boyden chamber containing Endocult Basal Medium with supplements and transmigrated cells were scored. The invasion index was expressed as the ratio between the numbers of invading cells relative to cell migration through a control insert membrane. For endotoxins, we used a commercially available system based on the kinetic chromogenic LAL-test. Validation of sterility was performed by direct inoculation of TSB and FTM media with the cell product following Eu Ph 2.6.1 guideline. Results and discussion The calculated MVD and endotoxin limit were 780× and 39 EU/ml respectively. The 1:10 and 1:100 dilutions were selected for the validation. For sterility, all the FTM cultures were positive after 3 days. For TSB cultures, Mycetes and B. subtilis were positive after 5 and 3 days respectively. The detection limit was 1-10 colonies. A total of four invasion assay were performed: the calculated invasion index was 28.89 ± 16.82% (mean ± SD. Conclusion We have validated a strategy for endotoxin, sterility and potency testing in an ATMP used in cardiac regeneration. Unlike pharmaceutical products, many stem-cell-based products may originate in hospitals where personnel are unfamiliar with the applicable regulations. As new ATMPs are developed, the regulatory framework is likely to evolve. Meanwhile, existing regulations provide an appropriate structure for

A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice.

Science.gov (United States)

Soncin, Sabrina; Lo Cicero, Viviana; Astori, Giuseppe; Soldati, Gianni; Gola, Mauro; Sürder, Daniel; Moccetti, Tiziano

2009-09-08

Main scope of the EU and FDA regulations is to establish a classification criterion for advanced therapy medicinal products (ATMP). Regulations require that ATMPs must be prepared under good manufacturing practice (GMP). We have validated a commercial system for the determination of bacterial endotoxins in compliance with EU Pharmacopoeia 2.6.14, the sterility testing in compliance with EU Pharmacopoeia 2.6.1 and a potency assay in an ATMP constituted of mononucleated cells used in cardiac regeneration. For the potency assay, cells were placed in the upper part of a modified Boyden chamber containing Endocult Basal Medium with supplements and transmigrated cells were scored. The invasion index was expressed as the ratio between the numbers of invading cells relative to cell migration through a control insert membrane. For endotoxins, we used a commercially available system based on the kinetic chromogenic LAL-test. Validation of sterility was performed by direct inoculation of TSB and FTM media with the cell product following Eu Ph 2.6.1 guideline. The calculated MVD and endotoxin limit were 780x and 39 EU/ml respectively. The 1:10 and 1:100 dilutions were selected for the validation. For sterility, all the FTM cultures were positive after 3 days. For TSB cultures, Mycetes and B. subtilis were positive after 5 and 3 days respectively. The detection limit was 1-10 colonies. A total of four invasion assay were performed: the calculated invasion index was 28.89 +/- 16.82% (mean +/- SD). We have validated a strategy for endotoxin, sterility and potency testing in an ATMP used in cardiac regeneration. Unlike pharmaceutical products, many stem-cell-based products may originate in hospitals where personnel are unfamiliar with the applicable regulations. As new ATMPs are developed, the regulatory framework is likely to evolve. Meanwhile, existing regulations provide an appropriate structure for ensuring the safety and efficacy of the next generation of ATMPs. Personnel

21 CFR 111.205 - What is the requirement to establish a master manufacturing record?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What is the requirement to establish a master manufacturing record? 111.205 Section 111.205 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

Guide to good practices for on-the-job training

Energy Technology Data Exchange (ETDEWEB)

1992-07-01

The purpose of the Department of Energy (DOE) Guide to Good Practices for On-the-Job Training (OJT) is to provide DOE contractor organizations with information that can be used to modify existing programs or to develop new programs. This guide replaces the Guide to Good Practices for On-the-Job Training that was distributed to DOE and DOE contractors in 1987. DOE contractors should not feel obligated to adopt all parts of this guide. Rather, they can use the information in this guide to develop programs that apply to their facility. This guide can be used as an aid in the design and development of a facility's OJT programs and to assist the instructors who conduct OJT and performance tests in the areas of facility operations, maintenance, and technical supports.

78 FR 22887 - Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices...

Science.gov (United States)

2013-04-17

... for Preventing Cross- Contamination; Availability AGENCY: Food and Drug Administration, HHS. ACTION... require separation of manufacturing facilities to avoid cross-contamination, the only class of products... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0104...

ASSESSMENT OF GOOD PRACTICES IN HOSPITAL FOOD SERVICE BY COMPARING EVALUATION TOOLS.

Science.gov (United States)

Macedo Gonçalves, Juliana; Lameiro Rodrigues, Kelly; Santiago Almeida, Ângela Teresinha; Pereira, Giselda Maria; Duarte Buchweitz, Márcia Rúbia

2015-10-01

since food service in hospitals complements medical treatment, it should be produced in proper hygienic and sanitary conditions. It is a well-known fact that food-transmitted illnesses affect with greater severity hospitalized and immunosuppressed patients. good practices in hospital food service are evaluated by comparing assessment instruments. good practices were evaluated by a verification list following Resolution of Collegiate Directory n. 216 of the Brazilian Agency for Sanitary Vigilance. Interpretation of listed items followed parameters of RCD 216 and the Brazilian Association of Collective Meals Enterprises (BACME). Fisher's exact test was applied to detect whether there were statistically significant differences. Analysis of data grouping was undertaken with Unweighted Pair-group using Arithmetic Averages, coupled to a correlation study between dissimilarity matrixes to verify disagreement between the two methods. Good Practice was classified with mean total rates above 75% by the two methods. There were statistically significant differences between services and food evaluated by BACME instrument. Hospital Food Services have proved to show conditions of acceptable good practices. the comparison of interpretation tools based on RCD n. 216 and BACME provided similar results for the two classifications. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Report of the consultants meeting on good manufacturing practices and clean room requirements for radiopharmaceuticals

International Nuclear Information System (INIS)

2000-07-01

be carried out in special facilities often with shielding and remote handling to protect the operators from radiation exposure. There are international norms for radiation exposure allowed for radiation workers and strong national organizations for monitoring and implementing radiation protection measures. Being part of the national nuclear programmes, radiopharmaceutical production has been from the very beginning subjected to regulations of radioactive material handling, transportation and use. However, the systems of surveillance and control for pharmaceutical products have not been implemented in many places to the same extent as for radiation protection. There are also technical difficulties in harmonizing the requirements of radiation safety and pharmaceutical safety. Simultaneously, there have been several technical developments in the field of Quality Assurance of pharmaceuticals. The concepts of Good Manufacturing Practices (GMP) and the requirements for clean rooms define quality of air for pharmaceutical production areas. Efforts have been made in recent years to apply these concepts also to radiopharmaceutical production. Significant progress appears to have been made in the developed countries and in the technology needed to fulfil these standards. The technical problems in upgrading the facilities of radioisotope laboratories to conform with the clean air requirements and the cost involved are still to be clearly understood in many developing countries. In many countries the regulatory authorities apply the same set of regulations for radiopharmaceuticals as for other pharmaceuticals. Some guidelines for radiopharmaceuticals have been published, e.g. Scandinavian, US FDA, Australian, Canadian and EU guidelines. No such guidelines are yet available from international agencies such as the International Atomic Energy Agency (IAEA) or World Health Organization (WHO). A guideline from an international body of this nature would be very useful for institutions

GUIDING PRINCIPLES FOR GOOD PRACTICES IN HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT UNITS.

Science.gov (United States)

Sampietro-Colom, Laura; Lach, Krzysztof; Pasternack, Iris; Wasserfallen, Jean-Blaise; Cicchetti, Americo; Marchetti, Marco; Kidholm, Kristian; Arentz-Hansen, Helene; Rosenmöller, Magdalene; Wild, Claudia; Kahveci, Rabia; Ulst, Margus

2015-01-01

Health technology assessment (HTA) carried out for policy decision making has well-established principles unlike hospital-based HTA (HB-HTA), which differs from the former in the context characteristics and ways of operation. This study proposes principles for good practices in HB-HTA units. A framework for good practice criteria was built inspired by the EFQM excellence business model and information from six literature reviews, 107 face-to-face interviews, forty case studies, large-scale survey, focus group, Delphi survey, as well as local and international validation. In total, 385 people from twenty countries have participated in defining the principles for good practices in HB-HTA units. Fifteen guiding principles for good practices in HB-HTA units are grouped in four dimensions. Dimension 1 deals with principles of the assessment process aimed at providing contextualized information for hospital decision makers. Dimension 2 describes leadership, strategy and partnerships of HB-HTA units which govern and facilitate the assessment process. Dimension 3 focuses on adequate resources that ensure the operation of HB-HTA units. Dimension 4 deals with measuring the short- and long-term impact of the overall performance of HB-HTA units. Finally, nine core guiding principles were selected as essential requirements for HB-HTA units based on the expertise of the HB-HTA units participating in the project. Guiding principles for good practices set up a benchmark for HB-HTA because they represent the ideal performance of HB-HTA units; nevertheless, when performing HTA at hospital level, context also matters; therefore, they should be adapted to ensure their applicability in the local context.

Electronic business model for small- and medium-sized manufacturing enterprises (SME): a case study

Science.gov (United States)

Yuen, Karina; Chung, Walter W.

2001-10-01

This paper identifies three essential factors (information infrastructure, executive information system and a new manufacturing paradigm) that are used to support the development of a new business model for competitiveness. They facilitate changes in organization structure in support of business transformation. A SME can source a good manufacturing practice using a model of academic-university collaboration to gain competitive advantage in the e-business world. The collaboration facilitates the change agents to use information systems development as a vehicle to increase the capability of executives in using information and knowledge management to gain higher responsiveness and customer satisfaction. The case company is used to illustrate the application of a web-based executive information system to interface internal communications with external operation. It explains where a good manufacturing practice may be re-applied by other SMEs to acquire skills as a learning organization grows in an extended enterprise setting.

Good practices for improved nuclear power plant performance

International Nuclear Information System (INIS)

1989-04-01

This report provides an overview of operational principles, practice and improvements which have contributed to good performance of eight selected world nuclear power stations. The IAEA Power Reactor Information System (PRIS) was used to identify a population of good performers. It is recognized that there are many other good performing nuclear power stations not included in this report. Specific criteria described in the introduction were used in selecting these eight stations. The information contained in this report was obtained by the staff from IAEA, Division of Nuclear Power. This was accomplished by visits to the stations and visits to a number of utility support groups and three independent organizations which provide support to more than one utility. The information in this report is intended as an aid for operating organizations to identify possible improvement initiatives to enhance plant performance. Figs and tabs

A practical discussion of risk management for manufacturing of pharmaceutical products.

Science.gov (United States)

Mollah, A Hamid; Baseman, Harold S; Long, Mike; Rathore, Anurag S

2014-01-01

Quality risk management (QRM) is now a regulatory expectation, and it makes good business sense. The goal of the risk assessment is to increase process understanding and deliver safe and effective product to the patients. Risk analysis and management is an acceptable and effective way to minimize patient risk and determine the appropriate level of controls in manufacturing. While understanding the elements of QRM is important, knowing how to apply them in the manufacturing environment is essential for effective process performance and control. This article will preview application of QRM in pharmaceutical and biopharmaceutical manufacturing to illustrate how QRM can help the reader achieve that objective. There are several areas of risk that a drug company may encounter in pharmaceutical manufacturing, specifically addressing oral solid and liquid formulations. QRM tools can be used effectively to identify the risks and develop strategy to minimize or control them. Risks are associated throughout the biopharmaceutical manufacturing process-from raw material supply through manufacturing and filling operations to final distribution via a controlled cold chain process. Assessing relevant attributes and risks for biotechnology-derived products is more complicated and challenging for complex pharmaceuticals. This paper discusses key risk factors in biopharmaceutical manufacturing. Successful development and commercialization of pharmaceutical products is all about managing risks. If a company was to take zero risk, most likely the path to commercialization would not be commercially viable. On the other hand, if the risk taken was too much, the product is likely to have a suboptimal safety and efficacy profile and thus is unlikely to be a successful product. This article addresses the topic of quality risk management with the key objective of minimizing patient risk while creating an optimal process and product. Various tools are presented to aid implementation of these

2 CFR 176.140 - Award term-Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

Science.gov (United States)

2010-01-01

..., tunnels, sewers, mains, power lines, pumping stations, heavy generators, railways, airports, terminals...) Domestic preference. (1) This award term and condition implements Section 1605 of the American Recovery and... the domestic iron, steel, and/or manufactured goods would be unreasonable. The cost of domestic iron...

Tools to share good chairside teaching practice: a clinical scenario and appreciative questionnaire.

Science.gov (United States)

Sweet, J; Wilson, J; Pugsley, L; Schofield, M

2008-12-13

This article provides a scenario for analysis of good chairside teaching practice to serve as a starting point for continued discussion in this complex field. Documented issues of good chairside teaching practice are cross-referenced to a clinical scenario with explanations in the form of a commentary. This provided the context for generating a set of questions that are provided as tools to support good chairside practice. These tools are designed to be used with 'Appreciative Inquiry', which claims that there is much to be gained by discovering where excellence is possible and elaborating upon this. Although this process can be carried out in single units or departments, it is proposed that collaboration between institutions would allow sharing of valuable innovations and greater understanding of educational training, production of good practice guidance and professional development of staff. This article is the third in a series of three and provides a scaffold for a scenario and questions to encourage collaboration in evolving and sharing good chairside teaching practice. The first article investigated the perceptions of stakeholders in chairside teaching at a single dental school and the second evaluated chairside teaching on a UK wide scale. A further accompanying article reviews some of the educational methodology and innovations in teaching and learning that may be applied to dentistry.

Materials Selection And Fabrication Practices For Food Processing Equipment Manufacturers In Uganda

Directory of Open Access Journals (Sweden)

John Baptist Kirabira

2017-08-01

Full Text Available The food processing industry is one of the fast-growing sub-sectors in Uganda. The industry which is majorly composed of medium and small scale firms depends on the locally developed food processing equipment. Due to lack of effective materials selection practices employed by the equipment manufacturers the materials normally selected for most designs are not the most appropriate ones hence compromising the quality of the equipment produced. This has not only led to poor quality food products due to contamination but could also turn out health hazardous to the consumers of the food products. This study involved the assessment of the current materials selection and fabrication procedures used by the food processing equipment manufacturers with a view of devising best practices that can be used to improve the quality of the food products processed by the locally fabricated equipment. Results of the study show that designers experience biasness and desire to minimize cost compromise the materials selection procedure. In addition to failing to choose the best material for a given application most equipment manufacturers are commonly fabricating equipment with inadequate surface finish and improper weldments. This hinders the equipments ability to meet food hygiene standards.

Distance Learning. Leonardo da Vinci Series: Good Practices.

Science.gov (United States)

Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

This brochure, part of a series about good practices in vocational training in the European Union, describes 12 projects that use distance learning to promote lifelong learning in adults. The projects and their countries of origin are as follows: (1) 3D Project, training in the use of IT tools for 3D simulation and animation and practical…

Investment Decision Making: A Guide to Good Practice.

Science.gov (United States)

Higher Education Funding Council for England, Bristol.

This "good practice" guide is aimed at anyone in higher education in England who is involved in making decisions on investments. It focuses on the principles to be followed, rather than the techniques of appraisal. The guide outlines the steps for developing an outline business case and then refining it into a full business case for the…

OSART good practices: 1986-1989

International Nuclear Information System (INIS)

1991-05-01

The IAEA Operational Safety Review Team (OSART) programme provides advice and assistance to Member States for enhancing the operational safety of nuclear power plants (NPP). OSART teams started to identify good practices (GP), as examples of excellence in NPP operation, in 1986. This report is the first of its kind and summarizes GP for the period January 1986 to June 1989. The information in the report is presented in three different ways to facilitate access: The table of contents which present the GP at the NPP visited by OSART teams in the order of visits; the listing of the GP according to the eight standard areas of review, giving the NPP concerned and the relevant report page; the permutated index of the titles of the GP. 1 tab

A pilot-scale nonwoven roll goods manufacturing process reduces microbial burden to pharmacopeia acceptance levels for nonsterile hygiene applications

Science.gov (United States)

A total of seven source fiber types were selected for use in the manufacturing of nonwoven roll goods: polyester; polypropylene; rayon; greige cotton from two sources; mechanically cleaned greige cotton; and scoured and bleached cotton. The microbial burden of each source fiber was measured as a pr...

Evaluation of green manufacturing practices using a hybrid MCDM model combining DANP with PROMETHEE

DEFF Research Database (Denmark)

Govindan, Kannan; Kannan, Devika; Shankar, Madan

2015-01-01

The advent of increasing industrialisation and globalisation has put pressure on Indian enterprises to increase the integration of environmentally conscious manufacturing practices into their operations. Numerous studies have explored this strategy but there are significant gaps in the existing......-criteria decision-making model combining DEMATEL based on ANP (DANP) with Preference Ranking Organisation METHod for Enrichment Evaluations. A methodological framework is proposed to evaluate GMP and the same is validated within a particular single case industry situated in the southern part of India, who...... is the leading manufacturer of rubber tyres and tubes. By virtue of these findings, industries can identify the best GM practice to adopt in order to increase the chances of profit and performance throughout their systems. This study concludes by successfully identifying the best GM practice for this case...

Good Practices In Instructional Process Among Current Educational Programs For Basic Education In Indonesia

Directory of Open Access Journals (Sweden)

Laurens Kaluge

2016-02-01

Full Text Available Comparing the good practices in the area of teaching learning improvement, several points are raised here. The five programs covering teaching learning improvement component are MBE, CLCC, NTT-PEP, SEQIP, and CTL. Through a survey in seven provinces, data were collected from various bureaucrats, school practitioners, students, and their parents. Within the component of the teaching learning improvement there are several elements which are commonly available among the projects. Those elements are preparation of good teachers, provision and development of resources, and practice teaching learning activities are considered to be good practices.

CHRODIS criteria applied to the MASK (MACVIA-ARIA Sentinel NetworK) Good Practice in allergic rhinitis

DEFF Research Database (Denmark)

Bousquet, J; Onorato, G L; Bachert, C

2017-01-01

A Good Practice is a practice that works well, produces good results, and is recommended as a model. MACVIA-ARIA Sentinel Network (MASK), the new Allergic Rhinitis and its Impact on Asthma (ARIA) initiative, is an example of a Good Practice focusing on the implementation of multi-sectoral care pa...

Agronomy, sustainability and good agricultural practices

Directory of Open Access Journals (Sweden)

Caliman Jean-Pierre

2005-03-01

Full Text Available Sustainable palm oil production needs to be based on the application of a code of good practices, respecting a certain number of criteria related to economic, environmental and social aspects. We focus here on economic and environmental aspects, attempting to take stock of the current situation regarding the management of inputs (fertilizers, pesticides, and of oil mill waste (empty fruit bunches, effluent. We also take a look at the main agricultural research required if we are to be able to assess the situation on different scales and see how it is evolving, and also provide assistance for rational management that is compatible with farmers’ production targets.

Best Manufacturing Practices: Report of Survey Conducted at Weirton Steel Corporation, Weirton, WV

National Research Council Canada - National Science Library

Renner, Ernie

1996-01-01

This report was produced by the Best Manufacturing Practices (BMP) program, a unique industry and government cooperative technology transfer effort that improves the competitiveness of America's industrial base both here and abroad...

Prakriti-based research: Good reporting practices.

Science.gov (United States)

Bhalerao, Supriya; Patwardhan, Kishor

2016-03-01

The recent advances in the fields of genomics, personalized medicine, and Ayurveda have motivated many researchers to look at the relationship between Prakriti (phenotype-based Ayurveda constitution) and various objective biological parameters. As a result, a number of studies reporting such a relationship have made their way into mainstream scholarly journals. However, when it comes to the protocols that these workers follow to identify one's Prakriti, there are several issues that are yet to be resolved. In this communication, we propose a few reporting practices that such workers are required to be encouraged to follow, while submitting their work on Prakriti to scholarly journals. We have arranged this proposal under the following domains that may serve as a preliminary checklist in this context: The textual references, validation process, assessment of characters, scoring pattern, weightage assignment, criterion for expressing the final Prakriti type, and a need to publish the complete Prakriti-determination tool. We advocate that only if the workers in the field adhere to these good reporting practices, one will be able to draw meaningful, generalizable, and applicable interpretations out of such studies. We also suggest that the editors of relevant scholarly journals may recommend these reporting practices while considering such reports for publication. Copyright © 2016 Transdisciplinary University, Bangalore and World Ayurveda Foundation. Published by Elsevier B.V. All rights reserved.

The application of Quick Response Manufacturing practices in Brazil, Europe, and the USA : An exploratory study

NARCIS (Netherlands)

Godinho Filho, Moacir; Marchesini, Antonio Gilberto; Riezebos, Jan; Vandaele, Nico; Devos Ganga, Gilberto Miller

2017-01-01

This research investigates the application of Quick Response Manufacturing (QRM) practices by enterprises in Brazil, Europe, and the USA. QRM is a management concept that focuses on time as the key factor in competitive manufacturing, particularly in customer-oriented Engineer and Make to Order

Guide of good practices for occupational radiological protection in plutonium facilities

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-06-01

This Technical Standard (TS) does not contain any new requirements. Its purpose is to provide guides to good practice, update existing reference material, and discuss practical lessons learned relevant to the safe handling of plutonium. the technical rationale is given to allow US Department of Energy (DOE) health physicists to adapt the recommendations to similar situations throughout the DOE complex. Generally, DOE contractor health physicists will be responsible to implement radiation protection activities at DOE facilities and DOE health physicists will be responsible for oversight of those activities. This guidance is meant to be useful for both efforts. This TS replaces PNL-6534, Health Physics Manual of Good Practices for Plutonium Facilities, by providing more complete and current information and by emphasizing the situations that are typical of DOE`s current plutonium operations; safe storage, decontamination, and decommissioning (environmental restoration); and weapons disassembly.

[Identifying indicators of good practice in clinical and healthcare management].

Science.gov (United States)

Bermúdez Tamayo, C; Olry de Labry Lima, A; García Mochón, L

2018-03-06

To identify good practices in order to develop and implement indicators of health outcomes for clinical and healthcare management, as well as the characteristics for an indicator to be considered adequate. A scoping review was performed, with the following phases: 1) Search and identification of bibliography. 2) Selection of relevant documents. Including those studies that discussed issues related to good practices for the use of health indicators in the management field. Those published in a language other than English or Spanish or before 2006 were excluded. 3) Analysis and extraction of information. 4) Consultation with stakeholders, using a qualitative methodology through Concept Mapping, with the participation of 40 experts (decision-makers, scientific societies, and health professionals). The data collection process included an inductive and structured procedure, with prioritisation of ideas grouped into clusters, according to feasibility and importance criteria (0-10 scale). Good practices identified 2 levels: 1) macro-management: Define a framework for the evaluation of indicators and establish a benchmark of indicators. 2) meso-management: Establish indicators according to evidence and expert consensus, taking into account priority areas and topics, testing before final use, and communicate results adequately. The characteristics of a suitable indicator are: 1) Approach of an important issue, 2) Scientific validity, 3) Possibility of measurement with reliable data, 4) Meaning of useful and applicable measurement, and 5) Wide scope. The best practices for the use of indicators in clinical and healthcare management can make it easier to monitor performance and accountability, as well as to support the decision-making addressed at the development of initiatives for quality improvement. Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

VET Providers Planning to Deliver Degrees: Good Practice Guide

Science.gov (United States)

National Centre for Vocational Education Research (NCVER), 2015

2015-01-01

This good practice guide is intended to assist public and private registered training organisations (RTOs) planning to commence higher education (HE) delivery. The guide is based on research undertaken by Victor Callan and Kaye Bowman, who completed case studies with six providers currently delivering higher education qualifications in addition to…

Guide to good practices at plutonium facilities

International Nuclear Information System (INIS)

Faust, L.G.; Brackenbush, L.W.; Carter, L.A.; Endres, G.W.R.; Glenn, R.D.; Jech, J.J.; Selby, J.M.; Smith, R.C.; Waite, D.A.; Walsh, W.P.

1977-09-01

This manual establishes guidelines and principles for use in setting up a sound radiation protection program for work with plutonium. The guidance presented is based on the experiences of Energy Research and Development Administration (ERDA) contractors and those portions of private industry concerned with the operation of plutonium facilities, specifically with the fabrication of mixed oxide reactor fuel. The manual is directed primarily to those facilities which have as their sole purpose the handling of large quantities of plutonium for military or industrial uses. It is not intended for use by facilities engaged in reactor or chemical separation operations nor for partial or occasional use by analytical laboratories; while these facilities would find the manual beneficial, it would be incomplete for their needs. The manual addresses good practices that should be observed by management, staff and designers, since the benefits of a good radiation protection program are the result of their joint efforts. Methods for the diagnostic evaluation of internally deposited Pu are included

The impact of preventive maintenance practices on manufacturing performance: A proposed model for SMEs in Malaysia

Science.gov (United States)

Lazim, Halim Mad; Taib, Che Azlan; Lamsali, Hendrik; Saleh, Mohamed Najib; Subramaniam, Chandrakantan

2016-08-01

Preventive maintenance (PM) plays important role to avoid or mitigate potential stoppages and disruptions of equipment or machinery from occurring in daily operations. PM emphasized total employee involvement and it is important for companies as well as Small and Medium Sized Enterprises (SMEs). SME sectors contribution to the Malaysian economy makes up 95% of the total manufacturers, however PM remain relatively lacking. The ability, reliability and effective maintenance management is highly important in order to achieve desired manufacturing performance. Therefore, organizational capability in planning, controlling, implementing and monitoring PM activities is important. Furthermore, empirical evidence on the potential impact of PM practices towards manufacturing performance with organizational capability as a moderating effect is still limited and indecisive. Henceforth, this paper aims to explore and investigate potential relationships between PM practices and manufacturing performance moderated by organizational capability in the contact of Malaysian SMEs in the manufacturing sector. Correspondently, the study intends to propose a new research framework and hypotheses to examine the abovementioned relationships. The proposed framework includes PM team, PM strategy and planned maintenance as the determinants, while organizational capability serves as the moderating variable. Manufacturing performance will be viewed in terms of innovation and financial factors. Proposed research direction and conclusion are discussed at the end of the study.

Charter of good practices in industrial radiography

International Nuclear Information System (INIS)

2010-01-01

This document describes good practices in the field of industrial radiography. After having presented the main prevention and radiation protection principles, the actors inside and outside of the company, and actors intervening during an operation subcontracting in industrial radiography, this report analyzes the activity: prerequisites for work preparation, prevention coordination, work preparation, transportation, work achievement, return on experience. It addresses personnel training and information, and the dosimetric and medical monitoring of technicians in industrial radiography. Some aspects are addressed in appendix: principles (justification, optimization, and limitation), regulations, intervention form, exposure form, and so on

Implementing Good Practices Programs to Encourage Production of High-Quality, Safer Produce in Mississippi

Science.gov (United States)

Mahmoud, Barakat S. M.; Stafne, Eric T.; Coker, Christine H.; Bachman, Gary R.; Bell, Nicole

2016-01-01

Fifty-four growers/producers attended four 1-day good agricultural practices (GAP) and good handling practices (GHP) workshops at four locations in Mississippi. Pre- and post workshop survey data indicated that the participants' food safety knowledge increased by 15%. Furthermore, the workshops helped producers develop their own food safety plans.…

Defending the four principles approach as a good basis for good medical practice and therefore for good medical ethics.

Science.gov (United States)

Gillon, Raanan

2015-01-01

This paper argues that the four prima facie principles-beneficence, non-maleficence, respect for autonomy and justice-afford a good and widely acceptable basis for 'doing good medical ethics'. It confronts objections that the approach is simplistic, incompatible with a virtue-based approach to medicine, that it requires respect for autonomy always to have priority when the principles clash at the expense of clinical obligations to benefit patients and global justice. It agrees that the approach does not provide universalisable methods either for resolving such moral dilemmas arising from conflict between the principles or their derivatives, or universalisable methods for resolving disagreements about the scope of these principles-long acknowledged lacunae but arguably to be found, in practice, with all other approaches to medical ethics. The value of the approach, when properly understood, is to provide a universalisable though prima facie set of moral commitments which all doctors can accept, a basic moral language and a basic moral analytic framework. These can underpin an intercultural 'moral mission statement' for the goals and practice of medicine. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The Impact Of Good Corporate Governance To Manufacturing Firm’s Profitability And Firm’s Value

Directory of Open Access Journals (Sweden)

Johanes Sumarno

2016-09-01

Full Text Available This paper studied the behavior of management toward the implementation of Good Corporate Governance in Indonesia to determine whether it has any influence towards profitability and its implication to the Manufacturing Firms’ value publicly listed in Indonesian Stock Exchange. There were 41 corporations who met the criteria of the survey. The data were analyzed using Panel Regression with fixed effects Model. The empirical findings show that the implementation of Corporate Governance in Indonesia has a positive, significant and direct impact toward firms’ profitability and firms’ value. Corporate Governance principles based on OECD principles that have positive and significant impact to both profitability and Firms’ Valueis Rights of Shareholders, Role of Stakeholders, Responsibilities of the Board Commissioners and Board of Directors. The principles that have significance and negative impact towards corporate profitability and value, are: Equitable treatment of shareholders and Disclosure and Transparencies. The most significant principle influencing profitability and firms’ value is Disclosure and Transparencies. Profitability plays a greater role in influencing Manufacturing Firms’ value in Indonesia. DOI: 10.15408/sjie.v5i2.3542

The importance of good time management in supporting succesful dental practice

Directory of Open Access Journals (Sweden)

Mita Juliawati

2016-06-01

Full Text Available n the globalization and Asean Economic Community (MEA era, especially in the era of  competition and modern dentistry, dentists need increasing services in order to maintain and increase patient visits. Especially in patient’s complain about dental services that caused by unmanaged time, such as late dentist, long queue of patients and time inefficiency in dental practice. The objective of this review is to discuss the importance of good time management ’in supporting successful dental pratice. Time management is the act or process of planning and exercising conscious control over the amount of time spent on specific activities, especially to increase  effectiveness, efficiency or productivity. Implementation in dental practice are as follow: planning, scheduling and time organizing to avoid wasted time. Proper time management resulted in greater efficiency and productivity, professional reputation,reduces stress and improves the image of dental practices. Routine evaluation is needed to increase time management quality. Efficient time management in dental practice requires organizing  individual tasks, analizing daily task, scheduling main projects, establishing deadlines and organizing workflow. The implementation in dental practice like organizing patients, medical and non medical employee daily schedule, managing the patient’s queue to get the minimum waiting time and avoiding doctors being late in giving services to patient. Setting good time management will make the dentist's work 'smarter not harder' to get more results with limited time. In principle all medical and non-medical personnel should support the implementation of service excellence in the health care services especially dental practice. The final objective in realizing good time management in dental clinic is concerning in quality service and aims to achieve patient satisfaction (customer satisfaction that the end goal is a loyal patient, customer loyalty and

Analyzing relationship between ERP utilization and lean manufacturing maturity of Turkish SMEs

DEFF Research Database (Denmark)

Iris, Cagatay; Cebeci, Ufuk

2014-01-01

with rapid development of information technology (IT) and progress in modern production management strategies have emerged. Obtained results show that Turkish SMEs have widely initiated lean production practices. However, applications are in initial level in the most cases. In respect to ERP systems...... is not adequate to make an inference about relationship between ERP and lean practices. Hence, a relational model is developed to analyze correlation between use of ERP and lean manufacturing implementation in white goods manufacturing SMEs of Istanbul, Turkey. Design/methodology/approach - The examination......Purpose - The purpose of this paper is to understand how effective Turkish small and medium size enterprises (SMEs) use enterprise resource planning (ERP) systems in module aspect and to assess the adherence to lean manufacturing requirements. Obtaining each efficiency result separately...

Effects of Piracy on Quality of Information Goods

OpenAIRE

Atanu Lahiri; Debabrata Dey

2013-01-01

It is commonly believed that piracy of information goods leads to lower profits, which translate to lower incentives to invest in innovation and eventually to lower-quality products. Manufacturers, policy makers, and researchers all claim that inadequate piracy enforcement efforts translate to lower investments in product development. However, we find many practical examples that contradict this claim. Therefore, to examine this claim more carefully, we develop a rigorous economic model of th...

Promoting good health research practice in low- and middle-income countries.

Science.gov (United States)

Mahendradhata, Yodi; Nabieva, Jamila; Ahmad, Riris Andono; Henley, Patricia; Launois, Pascal; Merle, Corinne; Maure, Christine; Horstick, Olaf; Elango, Varalakshmi

2016-01-01

Good clinical practice (GCP) guidelines have been the source of improvement in the quality of clinical trials; however, there are limitations to the application of GCP in the conduct of health research beyond industry-sponsored clinical trials. The UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Disease is promoting good practice in all health research involving human through the Good Health Research Practice (GHRP) training program initiative. To report the results of piloting the GHRP training program and formulate further steps to harness GHRP for promoting good practices in all health research involving human, particularly in low- and middle-income countries (LMICs). The objective of this training is to impart knowledge and skills for the application of ethical and quality principles to the design, conduct, recording, and reporting of health research involving human participants based on the level of risk, to ensure a fit-for-purpose quality system. This has been formulated into five sequential modules to be delivered in a 4-day course. Four courses have been organized in the pilot phase (2014-2015). The courses have been evaluated and assessed based on course feedback (quantitative and qualitative data) collected during course implementation and qualitative email-based pre- and post-course evaluation. Participants were highly satisfied with the course content and its organization. The relevance and applicability of the course content resulted in positive feedback and an articulated willingness to adapt and disseminate the course. Action points to strengthen the training program have been identified, and showed the imminent need to develop a consensus with a broader range of key stakeholders on the final set of GHRP standards and means for implementation. There is an urgent need to harness the momentum to promote high-quality and ethical health research in LMICs through scaling up GHRP training and further development of GHRP

Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3.

Science.gov (United States)

Battisti, Wendy P; Wager, Elizabeth; Baltzer, Lise; Bridges, Dan; Cairns, Angela; Carswell, Christopher I; Citrome, Leslie; Gurr, James A; Mooney, LaVerne A; Moore, B Jane; Peña, Teresa; Sanes-Miller, Carol H; Veitch, Keith; Woolley, Karen L; Yarker, Yvonne E

2015-09-15

This updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for individuals and organizations that contribute to the publication of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. The recommendations are designed to help individuals and organizations maintain ethical and transparent publication practices and comply with legal and regulatory requirements. These recommendations cover publications in peer-reviewed journals and presentations (oral or poster) at scientific congresses. The International Society for Medical Publication Professionals invited more than 3000 professionals worldwide to apply for a position on the steering committee, or as a reviewer, for this guideline. The GPP2 authors reviewed all applications (n = 241) and assembled an 18-member steering committee that represented 7 countries and a diversity of publication professions and institutions. From the 174 selected reviewers, 94 sent comments on the second draft, which steering committee members incorporated after discussion and consensus. The resulting guideline includes new sections (Principles of Good Publication Practice for Company-Sponsored Medical Research, Data Sharing, Studies That Should Be Published, and Plagiarism), expands guidance on the International Committee of Medical Journal Editors' authorship criteria and common authorship issues, improves clarity on appropriate author payment and reimbursement, and expands information on the role of medical writers. By following good publication practices (including GPP3), individuals and organizations will show integrity; accountability; and responsibility for accurate, complete, and transparent reporting in their publications and presentations.

Helping Displaced Older Workers Get Back into Employment: Good Practice Guide

Science.gov (United States)

Callahan, Victor J.; Bowman, Kaye

2015-01-01

This good practice guide is based on the report "Industry Restructuring and Job Loss: Helping Older Workers Get Back into Employment" by Victor J. Callan and Kaye Bowman. The aim of the research was to identify evidence-based practices that led to successful skills transfer, re-skilling, training and the attainment of new jobs for older…

Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing.

Science.gov (United States)

Mathaes, Roman; Mahler, Hanns-Christian; Roggo, Yves; Huwyler, Joerg; Eder, Juergen; Fritsch, Kamila; Posset, Tobias; Mohl, Silke; Streubel, Alexander

2016-01-01

Capping equipment used in good manufacturing practice manufacturing features different designs and a variety of adjustable process parameters. The overall capping result is a complex interplay of the different capping process parameters and is insufficiently described in literature. It remains poorly studied how the different capping equipment designs and capping equipment process parameters (e.g., pre-compression force, capping plate height, turntable rotating speed) contribute to the final residual seal force of a sealed container closure system and its relation to container closure integrity and other drug product quality parameters. Stopper compression measured by computer tomography correlated to residual seal force measurements.In our studies, we used different container closure system configurations from different good manufacturing practice drug product fill & finish facilities to investigate the influence of differences in primary packaging, that is, vial size and rubber stopper design on the capping process and the capped drug product. In addition, we compared two large-scale good manufacturing practice manufacturing capping equipment and different capping equipment settings and their impact on product quality and integrity, as determined by residual seal force.The capping plate to plunger distance had a major influence on the obtained residual seal force values of a sealed vial, whereas the capping pre-compression force and the turntable rotation speed showed only a minor influence on the residual seal force of a sealed vial. Capping process parameters could not easily be transferred from capping equipment of different manufacturers. However, the residual seal force tester did provide a valuable tool to compare capping performance of different capping equipment. No vial showed any leakage greater than 10(-8)mbar L/s as measured by a helium mass spectrometry system, suggesting that container closure integrity was warranted in the residual seal force range

Assessing the Importance of Domestic Vaccine Manufacturing Centers: An Overview of Immunization Programs, Vaccine Manufacture, and Distribution

Directory of Open Access Journals (Sweden)

Emma Rey-Jurado

2018-01-01

Full Text Available Vaccines have significantly reduced the detrimental effects of numerous human infectious diseases worldwide, helped to reduce drastically child mortality rates and even achieved eradication of major pathogens, such as smallpox. These achievements have been possible due to a dedicated effort for vaccine research and development, as well as an effective transfer of these vaccines to public health care systems globally. Either public or private institutions have committed to developing and manufacturing vaccines for local or international population supply. However, current vaccine manufacturers worldwide might not be able to guarantee sufficient vaccine supplies for all nations when epidemics or pandemics events could take place. Currently, different countries produce their own vaccine supplies under Good Manufacturing Practices, which include the USA, Canada, China, India, some nations in Europe and South America, such as Germany, the Netherlands, Italy, France, Argentina, and Brazil, respectively. Here, we discuss some of the vaccine programs and manufacturing capacities, comparing the current models of vaccine management between industrialized and developing countries. Because local vaccine production undoubtedly provides significant benefits for the respective population, the manufacture capacity of these prophylactic products should be included in every country as a matter of national safety.

Assessing the Importance of Domestic Vaccine Manufacturing Centers: An Overview of Immunization Programs, Vaccine Manufacture, and Distribution.

Science.gov (United States)

Rey-Jurado, Emma; Tapia, Felipe; Muñoz-Durango, Natalia; Lay, Margarita K; Carreño, Leandro J; Riedel, Claudia A; Bueno, Susan M; Genzel, Yvonne; Kalergis, Alexis M

2018-01-01

Vaccines have significantly reduced the detrimental effects of numerous human infectious diseases worldwide, helped to reduce drastically child mortality rates and even achieved eradication of major pathogens, such as smallpox. These achievements have been possible due to a dedicated effort for vaccine research and development, as well as an effective transfer of these vaccines to public health care systems globally. Either public or private institutions have committed to developing and manufacturing vaccines for local or international population supply. However, current vaccine manufacturers worldwide might not be able to guarantee sufficient vaccine supplies for all nations when epidemics or pandemics events could take place. Currently, different countries produce their own vaccine supplies under Good Manufacturing Practices, which include the USA, Canada, China, India, some nations in Europe and South America, such as Germany, the Netherlands, Italy, France, Argentina, and Brazil, respectively. Here, we discuss some of the vaccine programs and manufacturing capacities, comparing the current models of vaccine management between industrialized and developing countries. Because local vaccine production undoubtedly provides significant benefits for the respective population, the manufacture capacity of these prophylactic products should be included in every country as a matter of national safety.

Guide to good practices for equipment and piping labeling

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-12-01

This Guide to Good Practices is written to enhance understanding of, and provide direction for, Equipment and Piping Labeling, Chapter XVIII of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing labeling programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Equipment and Piping Labeling is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for a coordinated labeling program to promote safe and efficient operations.

9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

Science.gov (United States)

2010-01-01

... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... Sanitation Procedures § 147.26 Procedures for establishing isolation and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...

Management Practice of Supply Chain Quality Management in Service-oriented Manufacturing Industry

Directory of Open Access Journals (Sweden)

Gu Ping

2017-01-01

Full Text Available Supply chain quality management (SCQM in service-oriented manufacturing industries is needed in delivering value to customers in all process of supply chain management based on total quality management (TQM. In the paper, we identify the latest themes through reviewing prior quality management and supply chain management(SCM literature. In particular, we find manufacturing firms transform from providing products towards providing services, which means they need to go through fundamental changes especially in supply chains. We use a case study of Heilan Home to illustrate the SCQM themes and their ways in industrial practice. Based on our research, the case study, the experience of working with this firm, we propose a SCQM performance evaluation framework, as well as four strategies for other industries to improve customer satisfaction and added value. In this way can promote the transformation and upgrading of the manufacturing industry in the perspective of quality.

Regulating Cannabis Manufacturing: Applying Public Health Best Practices from Tobacco Control.

Science.gov (United States)

Orenstein, Daniel G; Glantz, Stanton A

2018-01-01

State legalization and regulation of cannabis, despite continued federal illegality, is a massive shift in regulatory approach. Manufactured cannabis, including concentrates, extracts, edibles, tinctures, topicals and other products, has received less attention than more commonly used dried flower, but represents emerging regulatory challenges due to additives, potency, consumption methods, and abuse and misuse potential. In November 2017, the California Department of Public Health (CDPH) released initial cannabis manufacturing regulations as part of a new state regulatory structure. As the largest U.S. medical cannabis market (and largest legal adult use market in the world beginning in 2018), California's regulatory approach will potentially influence national and global policy. Comparing CDPH's initial regulations to tobacco control best practices reveals that, while the regulations recognize the need to protect public health, prioritizing public health over business interests requires stronger approaches to labeling, packaging, and product formulations. Based on tobacco best practices, we recommend that cannabis regulations incorporate large and proportionately sized informational labels, a prominent universal cannabis symbol, rotating and pictorial health warnings, mandatory plain packaging, a comprehensive ban on characterizing flavors and addictive additives, and strict limits on the potency of inhalable products and those easily confused with non-cannabis products.

Survey of corporate social responsibility practices in Nigerian manufacturing sector

OpenAIRE

Akinyomi, Oladele John

2013-01-01

Based on stakeholders’ theory, this study examined the practice of corporate social responsibility by manufacturing companies in Nigeria. It employed survey research design to study 15 randomly selected companies in the food and beverages sector. A total of 225 questionnaires were administered to collect data. Data analysis revealed that CSR is a familiar concept in the sector as most of the companies do engage in CSR activities regularly. The major areas of focus of the CSR activities includ...

A Good Practice Guide on Critical Infor-mation Infrastructure Protection

NARCIS (Netherlands)

Luiijf, H.A.M.; Schie, T.C.C. van

2017-01-01

Early 2016, the Meridian Process and the GFCE tasked the Netherlands Organisation for Applied Scientific Research TNO to develop a Good Practice Guide on Critical Information Infrastructure Protection (CIIP) for governmental policy-makers [1]. The guide primarily aims at governmental policy-makers,

International Continence Society Good Urodynamic Practices and Terms 2016

DEFF Research Database (Denmark)

Rosier, Peter F W M; Schaefer, Werner; Lose, Gunnar

2017-01-01

AIMS: The working group initiated by the ICS Standardisation Steering Committee has updated the International Continence Society Standard "Good Urodynamic Practice" published in 2002. METHODS: On the basis of the manuscript: "ICS standard to develop evidence-based standards," a new ICS Standard......). RESULTS: This evidence-based ICS-GUP2016 has newly or more precisely defined more than 30 terms and provides standards for the practice, quality control, interpretation, and reporting of urodynamics; cystometry and pressure-flow analysis. Furthermore, the working group has included recommendations for pre......-testing information and for patient information and preparation. On the basis of earlier ICS standardisations and updating according to available evidence, the practice of uroflowmetry, cystometry, and pressure-flow studies are further detailed. CONCLUSION: ICS-GUP2016 updates and adds on to ICS-GUP2002 to improve...

Characterization of the animal by-product meal industry in Costa Rica: Manufacturing practices through the production chain and food safety.

Science.gov (United States)

Leiva, A; Granados-Chinchilla, F; Redondo-Solano, M; Arrieta-González, M; Pineda-Salazar, E; Molina, A

2018-06-01

Animal by-product rendering establishments are still relevant industries worldwide. Animal by-product meal safety is paramount to protect feed, animals, and the rest of the food chain from unwanted contamination. As microbiological contamination may arise from inadequate processing of slaughterhouse waste and deficiencies in good manufacturing practices within the rendering facilities, we conducted an overall establishment's inspection, including the product in several parts of the process.An evaluation of the Good Manufacturing Practices (GMP) was carried out, which included the location and access (i.e., admission) to the facilities, integrated pest management programs, physical condition of the facilities (e.g., infrastructure), equipments, vehicles and transportation, as well as critical control points (i.e., particle size and temperature set at 50 mm, 133°C at atmospheric pressure for 20 min, respectively) recommended by the OIE and the European Commission. The most sensitive points according to the evaluation are physical structure of the facilities (avg 42.2%), access to the facilities (avg 48.6%), and cleaning procedures (avg 51.4%).Also, indicator microorganisms (Salmonella spp., Clostridium spp., total coliforms, E. coli, E. coli O157:H7) were used to evaluate the safety in different parts of the animal meal production process. There was a prevalence of Salmonella spp. of 12.9, 14.3, and 33.3% in Meat and Bone Meal (MBM), poultry by-products, and fish meal, respectively. However, there were no significant differences (P = 0.73) in the prevalence between the different animal meals, according to the data collected.It was also observed that renderings associated with the poultry industry (i.e., 92.0%) obtained the best ratings overall, which reflects a satisfactory development of this sector and the integration of its production system as a whole.

Good control practices underlined by an on-line fuzzy control database

Directory of Open Access Journals (Sweden)

Alonso, M. V.

1994-04-01

Full Text Available In the olive oil trade, control systems that automate extraction processes, cutting production costs and increasing processing capacity without losing quality, are always desirable. The database structure of an on-line fuzzy control of centrifugation systems and the algorithms used to attain the best control conditions are analysed. Good control practices are suggested to obtain virgin olive oil of prime quality.

In the olive oil trade, control systems that automate extraction processes, cutting production costs and increasing processing capacity without losing quality, are always desirable. The database structure of an on-line fuzzy control of centrifugation systems and the algorithms used to attain the best control conditions are analysed. Good control practices are suggested to obtain virgin olive oil of prime quality.

A Study on Lean Manufacturing Practice Carried Out for Axle Housing Plant

Directory of Open Access Journals (Sweden)

Rishi J. P.

2018-01-01

Full Text Available Lean Manufacturing is a way to deal with the elimination of waste through persistent change within the system. The assembling units in India should likewise hope to take its preferences. The Industries are energetically following the Lean assembling strategies to reduce waste and cost. The present work is the study of a manufacturing process for axle housing and to decide how Lean manufacturing process carried out for axle housing plant to improve productivity. The new shot peening machine was installed in a heat treatment plant of a housing line in an automobile rear axle assembly plant and material handling time from storage to this new machine was more and this increased lead time subsequently. To reduce this Kaizens technique was employed and a direct gravity conveyor was chosen and installed between two work stations and the part was directly fed to the new machine installed and this reduces the material handling time considerably. A cost analysis was done to realize the benefits of implementing this lean technique. Therefore reducing lead time and increasing productivity is the Prime benefits of lean manufacturing practices like lean assembly.

Guide to good practices for developing learning objectives. DOE Handbook

Energy Technology Data Exchange (ETDEWEB)

NONE

1992-07-01

This guide to good practices provides information and guidance on the types of and development of learning objectives in a systematic approach to training program. This document can serve as a reference during the development of new learning objectives or refinement of existing ones.

Implementation of hierarchical design for manufacture rules in manufacturing processes

OpenAIRE

Parvez, Masud

2008-01-01

In order to shorten the product development cycle time, minimise overall cost and smooth transition into production, early consideration of manufacturing processes is important. Design for Manufacture (DFM) is the practice of designing products with manufacturing issues using an intelligent system, which translates 3D solid models into manufacturable features. Many existing and potential applications, particularly in the field of manufacturing, require various aspects of features technology. ...

Good Practice Guide Waste Minimization/Pollution Prevention

Energy Technology Data Exchange (ETDEWEB)

J Dorsey

1999-10-14

This Good Practice Guide provides tools, information, and examples for promoting the implementation of pollution prevention during the design phases of U.S. Department of Energy (DOE) projects. It is one of several Guides for implementing DOE Order 430.1, Life-cycle Asset Management. DOE Order 430.1 provides requirements for DOE, in partnership with its contractors, to plan, acquire, operate, maintain, and dispose of physical assets. The goals of designing for pollution prevention are to minimize raw material consumption, energy consumption, waste generation, health and safety impacts, and ecological degradation over the entire life of the facility (EPA 1993a). Users of this Guide will learn to translate national policy and regulatory requirements for pollution prevention into action at the project level. The Guide was written to be applicable to all DOE projects, regardless of project size or design phase. Users are expected to interpret the Guide for their individual project's circumstances, applying a graded approach so that the effort is consistent with the anticipated waste generation and resource consumption of the physical asset. This Guide employs a combination of pollution prevention opportunity assessment (PPOA) methods and design for environment (DfE) philosophies. The PPOA process was primarily developed for existing products, processes, and facilities. The PPOA process has been modified in this Guide to address the circumstances of the DOE design process as delineated in DOE Order 430.1 and its associated Good Practice Guides. This modified form of the PPOA is termed the Pollution Prevention Design Assessment (P2DA). Information on current nationwide methods and successes in designing for the environment also have been reviewed and are integrated into this guidance.

Promoting good health research practice in low- and middle-income countries

Directory of Open Access Journals (Sweden)

Yodi Mahendradhata

2016-08-01

Full Text Available Background: Good clinical practice (GCP guidelines have been the source of improvement in the quality of clinical trials; however, there are limitations to the application of GCP in the conduct of health research beyond industry-sponsored clinical trials. The UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Disease is promoting good practice in all health research involving human through the Good Health Research Practice (GHRP training program initiative. Objective: To report the results of piloting the GHRP training program and formulate further steps to harness GHRP for promoting good practices in all health research involving human, particularly in low- and middle-income countries (LMICs. Design: The objective of this training is to impart knowledge and skills for the application of ethical and quality principles to the design, conduct, recording, and reporting of health research involving human participants based on the level of risk, to ensure a fit-for-purpose quality system. This has been formulated into five sequential modules to be delivered in a 4-day course. Four courses have been organized in the pilot phase (2014–2015. The courses have been evaluated and assessed based on course feedback (quantitative and qualitative data collected during course implementation and qualitative email-based pre- and post-course evaluation. Results: Participants were highly satisfied with the course content and its organization. The relevance and applicability of the course content resulted in positive feedback and an articulated willingness to adapt and disseminate the course. Action points to strengthen the training program have been identified, and showed the imminent need to develop a consensus with a broader range of key stakeholders on the final set of GHRP standards and means for implementation. Conclusions: There is an urgent need to harness the momentum to promote high-quality and ethical health research in

Guide of good practices in medical physics - French Society of Medical Physics

International Nuclear Information System (INIS)

Rosenwald, Jean-Claude; Aventin, Christophe; Coste, Frederic; Francois, Pascal; Ginestet, Chantal; Perrin, Benedicte; Salvat, Cecile; Caselles, Olivier; Dedieu, Veronique; Dejean, Catherine; Batalla, Alain; Guillaume, Bonniaud; Le Du, Dominique; Lisbona, Albert; Marchesi, Vincent; Sarrazin, Thierry; Mazeron, Jean-Jacques; Lipinski, Francis; Vera, Pierre; Vermandel, Maximilien; Ducou le Pointe, Hubert; Vidal, Vincent; Henry, Cecile; Mazeau-Woynar, Valerie; Prot, Camille; Valero, Marc; Aubert, Bernard; Etard, Cecile; Jimonet, Christine; Roue, Amelie; Sage, Julie; Bardies, Manuel; Beauvais, Helene; Bey, Pierre; Costa, Andre; Desblancs, Claire; Eudaldo, Teresa; Farman, Bardia; Ferrand, Regis; Garcia, Robin; Giraud, Jean-Yves; Husson, Francois; Koulibaly, Malick; Carlan, Loic de; Manens, Jean-Pierre; Naudy, Suzanne; Noel, Alain; Pilette, Pierre; Verdun, Francis; Bouette, Aurelien; Breen, Stephen; Bridier, Andre; Chauvenet, Bruno; Chavaudra, Jean; Gardin, Isabelle; Herlevin, Karine

2012-01-01

After a presentation of the methodological approach used to write this book, the first chapter addresses the profession of medical physicist: medical physics in France (history, evolution of the profession, of the education and of regulation), legal framework (related to the medical use of ionizing radiations, legal texts directly concerning medical physics, regulations impacting the professional practice of medical physicists), scopes of intervention of the medical physicist (context, missions, dose management, image quality, quality management and safety, relationship with the patient, education, training and research, relationships with industry, cost management), operating conditions, and good professional practices. The second chapter addresses the principles of management of quality and safety: quality management in medical physics, safety management, quality and safety in health care facilities. The third part addresses good practices in medical physics: general principles of working methods, equipment management, participation to clinic activities

Practice-based Research Network Research Good Practices (PRGPs): Summary of Recommendations.

Science.gov (United States)

Dolor, Rowena J; Campbell-Voytal, Kimberly; Daly, Jeanette; Nagykaldi, Zsolt J; O'Beirne, Maeve; Sterling, Pamela; Fagnan, Lyle J; Levy, Barcey; Michaels, LeAnn; Louks, Hannah A; Smith, Paul; Aspy, Cheryl B; Patterson, V Beth; Kano, Miria; Sussman, Andrew L; Williams, Robert; Neale, Anne Victoria

2015-12-01

Practice-based research networks (PBRNs) conduct research in community settings, which poses quality control challenges to the integrity of research, such as study implementation and data collection. A foundation for improving research processes within PBRNs is needed to ensure research integrity. Network directors and coordinators from seven U.S.-based PBRNs worked with a professional team facilitator during semiannual in-person meetings and monthly conference calls to produce content for a compendium of recommended research practices specific to the context of PBRNs. Participants were assigned to contribute content congruent with their expertise. Feedback on the draft document was obtained from attendees at the preconference workshop at the annual PBRN meeting in 2013. A revised document was circulated to additional PBRN peers prior to finalization. The PBRN Research Good Practices (PRGPs) document is organized into four chapters: (1) Building PBRN Infrastructure; (2) Study Development and Implementation; (3) Data Management, and (4) Dissemination Policies. Each chapter contains an introduction, detailed procedures for each section, and example resources with information links. The PRGPs is a PBRN-specific resource to facilitate PBRN management and staff training, to promote adherence to study protocols, and to increase validity and generalizability of study findings. © 2015 Wiley Periodicals, Inc.

Guide to good practices for on-the-job training. DOE guideline

Energy Technology Data Exchange (ETDEWEB)

1992-07-01

The purpose of the Department of Energy (DOE) Guide to Good Practices for On-the-Job Training (OJT) is to provide DOE contractor organizations with information that can be used to modify existing programs or to develop new programs. This guide replaces the Guide to Good Practices for On-the-Job Training that was distributed to DOE and DOE contractors in 1987. DOE contractors should not feel obligated to adopt all parts of this guide. Rather, they can use the information in this guide to develop programs that apply to their facility. This guide can be used as an aid in the design and development of a facility`s OJT programs and to assist the instructors who conduct OJT and performance tests in the areas of facility operations, maintenance, and technical supports.

Simulation Design for Off-Line Training of Practical Lean Manufacturing Concepts for Visual Inspection

Science.gov (United States)

Tetteh, Edem; McWilliams, Douglas

2010-01-01

Customer needs for high-quality goods and the risk of product-liability litigation against businesses have made companies look for a way to sustain quality assurance in their products and services. Lean manufacturing is the latest and most successful system being used by companies to turn their business around. Visual inspection plays an important…

Multiple Criteria Decision Analysis for Health Care Decision Making--Emerging Good Practices: Report 2 of the ISPOR MCDA Emerging Good Practices Task Force.

Science.gov (United States)

Marsh, Kevin; IJzerman, Maarten; Thokala, Praveen; Baltussen, Rob; Boysen, Meindert; Kaló, Zoltán; Lönngren, Thomas; Mussen, Filip; Peacock, Stuart; Watkins, John; Devlin, Nancy

2016-01-01

Health care decisions are complex and involve confronting trade-offs between multiple, often conflicting objectives. Using structured, explicit approaches to decisions involving multiple criteria can improve the quality of decision making. A set of techniques, known under the collective heading, multiple criteria decision analysis (MCDA), are useful for this purpose. In 2014, ISPOR established an Emerging Good Practices Task Force. The task force's first report defined MCDA, provided examples of its use in health care, described the key steps, and provided an overview of the principal methods of MCDA. This second task force report provides emerging good-practice guidance on the implementation of MCDA to support health care decisions. The report includes: a checklist to support the design, implementation and review of an MCDA; guidance to support the implementation of the checklist; the order in which the steps should be implemented; illustrates how to incorporate budget constraints into an MCDA; provides an overview of the skills and resources, including available software, required to implement MCDA; and future research directions. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

An Exploratory Study on Implementation of Lean Manufacturing Practices(With Special Reference to Automobile Sector Industry(Yalın İmalat Faaliyetine Yönelik Bir Uygulama (Otomobil Endüstrisi Örneği

Directory of Open Access Journals (Sweden)

Er. Rajesh Kumar MEHTA

2012-01-01

Full Text Available At present scenario, Lean Manufacturing has become a world wide phenomenon. It is quite successful in drawing the attention of companies of all sizes. A large number of organizations are following Lean technologies and experiencing vast improvements in quality, production, customer service, and profitability. Lean Manufacturing is a systematic approach to identifying and eliminating waste through continuous improvement. The manufacturing industry in India must also look to leverage its advantages, its large domestic market, good conditions in terms of raw materials and skilled labour, and the quality focus. In India at the state level, there are few companies that are implementing Lean manufacturing techniques. In Dewas city, the industrial town of Madhya Pradesh, some of the automobile companies are vigorously following the Lean manufacturing techniques to eliminate waste and downsize the cost. Hence, all these factors prompted the researchers to analyze and study the implication of Lean Manufacturing Practices in Automobile Industries.

Utilizing reliability concepts in the development of IEEE recommended good practices for nuclear plant maintenance

International Nuclear Information System (INIS)

Gradin, L.P.

1986-01-01

This paper presents information describing the concern for nuclear power plant electrical equipment maintenance and the IEEE Nuclear Power Engineering Committee's method to address that concern. That method includes the creation of Working Group 3.3, ''Maintenance Good Practices'' which is developing specific maintenance good practice documents, supporting technical information exchange, and providing a vehicle to promote practices which can reduce cost and enhance plant safety. The foundation for that effort is the utilization of Reliability concepts

Good Laboratory Practice. Part 2. Recording and Retaining Raw Data

Science.gov (United States)

Wedlich, Richard C.; Libera, Agata E.; Pires, Amanda; Tellarini, Cassandra

2013-01-01

A clear understanding of how "raw data" is defined, recorded, and retained in the laboratory record is essential to the chemist employed in the laboratory compliant with the Good Laboratory Practices regulations. This article is intended to provide an understanding by drawing upon examples taken from the modern pharmaceutical analysis…

Adenovirus-mediated transfer of hepatocyte growth factor gene to human dental pulp stem cells under good manufacturing practice improves their potential for periodontal regeneration in swine.

Science.gov (United States)

Cao, Yu; Liu, Zhenhai; Xie, Yilin; Hu, Jingchao; Wang, Hua; Fan, Zhipeng; Zhang, Chunmei; Wang, Jingsong; Wu, Chu-Tse; Wang, Songlin

2015-12-15

Periodontitis is one of the most widespread infectious diseases in humans. We previously promoted significant periodontal tissue regeneration in swine models with the transplantation of autologous periodontal ligament stem cells (PDLSCs) and PDLSC sheet. We also promoted periodontal tissue regeneration in a rat model with a local injection of allogeneic bone marrow mesenchymal stem cells. The purpose of the present study is to investigate the roles of the hepatocyte growth factor (HGF) and human dental pulp stem cells (DPSCs) in periodontal tissue regeneration in swine. In the present study, we transferred an adenovirus that carried HGF gene into human DPSCs (HGF-hDPSCs) under good manufacturing practice (GMP) conditions. These cells were then transplanted into a swine model for periodontal regeneration. Twenty miniature pigs were used to generate periodontitis with bone defect of 5 mm in width, 7 mm in length, and 3 mm in depth. After 12 weeks, clinical, radiological, quantitative and histological assessment of regenerated periodontal tissues was performed to compare periodontal regeneration in swine treated with cell implantation. Our study showed that injecting HGF-hDPSCs into this large animal model could significantly improve periodontal bone regeneration and soft tissue healing. A hDPSC or HGF-hDPSC sheet showed superior periodontal tissue regeneration compared to the injection of dissociated cells. However, the sheets required surgical placement; thus, they were suitable for surgically-managed periodontitis treatments. The adenovirus-mediated transfer of the HGF gene markedly decreased hDPSC apoptosis in a hypoxic environment or in serum-free medium, and it increased blood vessel regeneration. This study indicated that HGF-hDPSCs produced under GMP conditions significantly improved periodontal bone regeneration in swine; thus, this method represents a potential clinical application for periodontal regeneration.

Knowledge Gained from Good Agricultural Practices Courses for Iowa Growers

Science.gov (United States)

Shaw, Angela; Strohbehn, Catherine; Naeve, Linda; Domoto, Paul; Wilson, Lester

2015-01-01

Good Agricultural Practices (GAP) educational courses provide produce growers with the fundamental information for producing and processing safe produce. To determine the effectiveness of the current 7-hour GAP course provided in Iowa, growers were surveyed before and 7-14 days after the course to determine changes in knowledge and opinions.…

Good practices in LIBS analysis: Review and advices

Energy Technology Data Exchange (ETDEWEB)

El Haddad, J.; Canioni, L.; Bousquet, B., E-mail: bruno.bousquet@u-bordeaux.fr

2014-11-01

This paper presents a review on the analytical results obtained by laser-induced breakdown spectroscopy (LIBS). In the first part, results on identification and classification of samples are presented including the risk of misclassification, and in the second part, results on concentration measurement based on calibration are accompanied with significant figures of merit including the concept of accuracy. Both univariate and multivariate approaches are discussed with special emphasis on the methodology, the way of presenting the results and the assessment of the methods. Finally, good practices are proposed for both classification and concentration measurement.

Good practices in LIBS analysis: Review and advices

International Nuclear Information System (INIS)

El Haddad, J.; Canioni, L.; Bousquet, B.

2014-01-01

This paper presents a review on the analytical results obtained by laser-induced breakdown spectroscopy (LIBS). In the first part, results on identification and classification of samples are presented including the risk of misclassification, and in the second part, results on concentration measurement based on calibration are accompanied with significant figures of merit including the concept of accuracy. Both univariate and multivariate approaches are discussed with special emphasis on the methodology, the way of presenting the results and the assessment of the methods. Finally, good practices are proposed for both classification and concentration measurement

[Health technology assessment for decision-making in Latin America: good practice principles].

Science.gov (United States)

Pichon-Riviere, Andrés; Soto, Natalie C; Augustovski, Federico Ariel; García Martí, Sebastián; Sampietro-Colom, Laura

2018-02-19

Identify the most relevant, applicable, and priority good practice principles in health technology assessment (HTA) in Latin America, and potential barriers to implementing them in the region. HTA good practice principles postulated worldwide were identified and then explored through a deliberative process in a forum of evaluators, funders, and technology producers. Forty-two representatives from ten Latin American countries participated in the forum. The good practice principles postulated at the international level were considered valid and potentially applicable in Latin America. Five principles were identified as priorities and as having greater potential to be expanded at this time: transparency in carrying out HTA; involvement of stakeholders in the HTA process; existence of mechanisms to appeal decisions; existence of clear mechanisms for HTA priority-setting; and existence of a clear link between assessment and decision-making. The main challenge identified was to find a balance between application of these principles and available resources, to prevent the planned improvements from jeopardizing report production times and failing to meet decision-makers' needs. The main recommendation was to gradually advance in improving HTA and its link to decision-making by developing appropriate processes for each country, without attempting to impose, in the short term, standards taken from examples at the international level without adequate adaptation to the local context.

Good learning practices in the field of science and technology

Directory of Open Access Journals (Sweden)

Beatriz Amante García

2011-09-01

Full Text Available The European Higher Education Area (EHEA scenario offers a new framework in which the role of universities can be rethought, regardless of the field of new degrees and postgraduate Studies involved. Therefore, the roles of teachers and students might differ significantly as the student would be obliged to request teacher’s guidance in order to acquire not only knowledge, which could be easily obtained elsewhere (books, internet etc. , but also personal skills and, especially, those related to their future professional career.By the term “Good learning practices” we refer to those activities asociated with professorship itself  ,such as those of facilitating and guiding the student learning process, or rather, those activities which are aimed at the student´s thorough learning of specific  (related to the field of study and generic skills.It is now a common occurrence to describe the students of a given classroom as being little motivated and as having great interest in passing but not in actually learning. This fact is quite concerning, as it suggests that the student sees the university as a mere transaction by which they can obtain a degree, certifying that they are apt for the professional world,  where they consider the “real” learning will take place.A good classroom environment is essential for the generation of teaching-learning processes.  It is precisely because of this that we are able to raise the issue of effective practices among teachers who foster a suitable classroom dynamics facilitating, then, the targeted learning experience.  Within this context, there are some authors who discuss good practices by professors especially concerned on how to perform assessment and feedback to enhance student’s learning activity. Thus,  providing them with a deep and lasting impact. Generally speaking, the activities in question are those which enable the student to execute a learning process that will continue throughout

Manufacturing engineering and technology

CERN Document Server

Kalpakjian, Serope; Vijai Sekar, K S

2014-01-01

For courses in manufacturing processes at two- or four-year schools. An up-to-date text that provides a solid background in manufacturing processes. Manufacturing Engineering and Technology, SI Edition, 7e, presents a mostly qualitative description of the science, technology, and practice of manufacturing. This includes detailed descriptions of manufacturing processes and the manufacturing enterprise that will help introduce students to important concepts. With a total of 120 examples and case studies, up-to-date and comprehensive coverage of all topics, and superior two-color graphics, this text provides a solid background for manufacturing students and serves as a valuable reference text for professionals. Teaching and Learning Experience To provide a better teaching and learning experience, for both instructors and students, this program will: * Apply Theory and/or Research: An excellent overview of manufacturing conceptswith a balance of relevant fundamentals and real-world practices. * Engage Students: E...

Safety climate practice in Korean manufacturing industry

International Nuclear Information System (INIS)

Baek, Jong-Bae; Bae, Sejong; Ham, Byung-Ho; Singh, Karan P.

2008-01-01

Safety climate survey was sent to 642 plants in 2003 to explore safety climate practices in the Korean manufacturing plants, especially in hazardous chemical treating plants. Out of 642 plants contacted 195 (30.4%) participated in the surveys. Data were collected by e-mail using SQL-server and mail. The main objective of this study was to explore safety climate practices (level of safety climate and the underlying problems). In addition, the variables that may influence the level of safety climate among managers and workers were explored. The questionnaires developed by health and safety executive (HSE) in the UK were modified to incorporate differences in Korean culture. Eleven important factors were summarized. Internal reliability of these factors was validated. Number of employees in the company varied from less than 30 employees (9.2%) to over 1000 employees (37.4%). Both managers and workers showed generally high level of safety climate awareness. The major underlying problems identified were inadequate health and safety procedures/rules, pressure for production, and rule breaking. The length of employment was a significant contributing factor to the level of safety climate. In this study, participants showed generally high level of safety climate, and length of employment affected the differences in the level of safety climate. Managers' commitment to comply safety rules, procedures, and effective safety education and training are recommended

Safety climate practice in Korean manufacturing industry.

Science.gov (United States)

Baek, Jong-Bae; Bae, Sejong; Ham, Byung-Ho; Singh, Karan P

2008-11-15

Safety climate survey was sent to 642 plants in 2003 to explore safety climate practices in the Korean manufacturing plants, especially in hazardous chemical treating plants. Out of 642 plants contacted 195 (30.4%) participated in the surveys. Data were collected by e-mail using SQL-server and mail. The main objective of this study was to explore safety climate practices (level of safety climate and the underlying problems). In addition, the variables that may influence the level of safety climate among managers and workers were explored. The questionnaires developed by health and safety executive (HSE) in the UK were modified to incorporate differences in Korean culture. Eleven important factors were summarized. Internal reliability of these factors was validated. Number of employees in the company varied from less than 30 employees (9.2%) to over 1000 employees (37.4%). Both managers and workers showed generally high level of safety climate awareness. The major underlying problems identified were inadequate health and safety procedures/rules, pressure for production, and rule breaking. The length of employment was a significant contributing factor to the level of safety climate. In this study, participants showed generally high level of safety climate, and length of employment affected the differences in the level of safety climate. Managers' commitment to comply safety rules, procedures, and effective safety education and training are recommended.

Safety climate practice in Korean manufacturing industry

Energy Technology Data Exchange (ETDEWEB)

Baek, Jong-Bae [Department of Safety Engineering, Chungju National University, Chungju 380-702 (Korea, Republic of); Bae, Sejong [Department of Biostatistics, University of North Texas Health Science Center, 3500 Camp Bowie Boulevard, Fort Worth, TX 76107 (United States)], E-mail: sbae@hsc.unt.edu; Ham, Byung-Ho [Department of Industrial Safety, Ministry of Labor (Korea, Republic of); Singh, Karan P. [Department of Biostatistics, University of North Texas Health Science Center, 3500 Camp Bowie Boulevard, Fort Worth, TX 76107 (United States)

2008-11-15

Safety climate survey was sent to 642 plants in 2003 to explore safety climate practices in the Korean manufacturing plants, especially in hazardous chemical treating plants. Out of 642 plants contacted 195 (30.4%) participated in the surveys. Data were collected by e-mail using SQL-server and mail. The main objective of this study was to explore safety climate practices (level of safety climate and the underlying problems). In addition, the variables that may influence the level of safety climate among managers and workers were explored. The questionnaires developed by health and safety executive (HSE) in the UK were modified to incorporate differences in Korean culture. Eleven important factors were summarized. Internal reliability of these factors was validated. Number of employees in the company varied from less than 30 employees (9.2%) to over 1000 employees (37.4%). Both managers and workers showed generally high level of safety climate awareness. The major underlying problems identified were inadequate health and safety procedures/rules, pressure for production, and rule breaking. The length of employment was a significant contributing factor to the level of safety climate. In this study, participants showed generally high level of safety climate, and length of employment affected the differences in the level of safety climate. Managers' commitment to comply safety rules, procedures, and effective safety education and training are recommended.

Developing a tool for the preparation of GMP audit of pharmaceutical contract manufacturer.

Science.gov (United States)

Linna, Anu; Korhonen, Mirka; Mannermaa, Jukka-Pekka; Airaksinen, Marja; Juppo, Anne Mari

2008-06-01

Outsourcing is rapidly growing in the pharmaceutical industry. When the manufacturing activities are outsourced, control of the product's quality has to be maintained. One way to confirm contract manufacturer's GMP (Good Manufacturing Practice) compliance is auditing. Audits can be supported for instance by using GMP questionnaires. The objective of this study was to develop a tool for the audit preparation of pharmaceutical contract manufacturers and to validate its contents by using Delphi method. At this phase of the study the tool was developed for non-sterile finished product contract manufacturers. A modified Delphi method was used with expert panel consisting of 14 experts from pharmaceutical industry, authorities and university. The content validity of the developed tool was assessed by a Delphi questionnaire round. The response rate in Delphi questionnaire round was 86%. The tool consisted of 103 quality items, from which 90 (87%) achieved the pre-defined agreement rate level (75%). Thirteen quality items which did not achieve the pre-defined agreement rate were excluded from the tool. The expert panel suggested only minor changes to the tool. The results show that the content validity of the developed audit preparation tool was good.

National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities

Science.gov (United States)

Balamurugan, A.N.; Szot, Gregory L.; Kin, Tatsuya; Liu, Chengyang; Czarniecki, Christine W.; Barbaro, Barbara; Bridges, Nancy D.; Cano, Jose; Clarke, William R.; Eggerman, Thomas L.; Hunsicker, Lawrence G.; Kaufman, Dixon B.; Khan, Aisha; Lafontant, David-Erick; Linetsky, Elina; Luo, Xunrong; Markmann, James F.; Naji, Ali; Korsgren, Olle; Oberholzer, Jose; Turgeon, Nicole A.; Brandhorst, Daniel; Chen, Xiaojuan; Friberg, Andrew S.; Lei, Ji; Wang, Ling-jia; Wilhelm, Joshua J.; Willits, Jamie; Zhang, Xiaomin; Hering, Bernhard J.; Posselt, Andrew M.; Stock, Peter G.; Shapiro, A.M. James

2016-01-01

Eight manufacturing facilities participating in the National Institutes of Health–sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. PMID:27465220

Electron beam curing - taking good ideas to the manufacturing floor

International Nuclear Information System (INIS)

Saunders, C.; Lopata, V.; Barnard, J.; Stepanik, T.

2000-01-01

Acsion is exploiting several emerging electron beam EB applications ranging from composite curing and repair to viscose manufacturing. EB curing of composite structures offers several advantages: significantly reduced curing times; improvements in part quality and performance; reduced environmental and health concerns; improvements in material handling; and reduced overall manufacturing costs compared to thermal curing. The aerospace industry is developing EB technology in all of their market sectors, including military aviation and space products. Some specific products include cryogenic fuel tanks, improved canopy frames for jet aircraft, and the all-composite military aircraft. This paper discusses each of these opportunities. (author)

Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer.

Science.gov (United States)

Anyakora, Chimezie; Ekwunife, Obinna; Alozie, Faith; Esuga, Mopa; Ukwuru, Jonathan; Onya, Steve; Nwokike, Jude

2017-09-18

Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. The cost benefit of improving the quality of Chi Pharmaceuticals Limited's facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0-5.5). Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.

CHRODIS criteria applied to the MASK (MACVIA-ARIA Sentinel NetworK) Good Practice in allergic rhinitis: a SUNFRAIL report

NARCIS (Netherlands)

Bousquet, J.; Onorato, G. L.; Bachert, C.; Barbolini, M.; Bedbrook, A.; Bjermer, L.; de Sousa, J. Correia; Chavannes, N. H.; Cruz, A. A.; de Manuel Keenoy, E.; Devillier, P.; Fonseca, J.; Hun, S.; Kostka, T.; Hellings, P. W.; Illario, M.; Ivancevich, J. C.; Larenas-Linnemann, D.; Millot-Keurinck, J.; Ryan, D.; Samolinski, B.; Sheikh, A.; Yorgancioglu, A.; Agache, I.; Arnavielhe, S.; Bewick, M.; Annesi-Maesano, I.; Anto, J. M.; Bergmann, K. C.; Bindslev-Jensen, C.; Bosnic-Anticevich, S.; Bouchard, J.; Caimmi, D. P.; Camargos, P.; Canonica, G. W.; Cardona, V.; Carriazo, A. M.; Cingi, C.; Colgan, E.; Custovic, A.; Dahl, R.; Demoly, P.; de Vries, G.; Fokkens, W. J.; Fontaine, J. F.; Gemicioğlu, B.; Guldemond, N.; Gutter, Z.; Haahtela, T.; Hellqvist-Dahl, B.; Jares, E.; Joos, G.; Just, J.; Khaltaev, N.; Keil, T.; Klimek, L.; Kowalski, M. L.; Kull, I.; Kuna, P.; Kvedariene, V.; Laune, D.; Louis, R.; Magnan, A.; Malva, J.; Mathieu-Dupas, E.; Melén, E.; Menditto, E.; Morais-Almeida, M.; Mösges, R.; Mullol, J.; Murray, R.; Neffen, H.; O'Hehir, R.; Palkonen, S.; Papadopoulos, N. G.; Passalacqua, G.; Pépin, J. L.; Portejoie, F.; Price, D.; Pugin, B.; Raciborski, F.; Simons, F. E. R.; Sova, M.; Spranger, O.; Stellato, C.; Todo Bom, A.; Tomazic, P. V.; Triggiani, M.; Valero, A.; Valovirta, E.; Vandenplas, O.; Valiulis, A.; van Eerd, M.; Ventura, M. T.; Wickman, M.; Young, I.; Zuberbier, T.; Zurkuhlen, A.; Senn, A.

2017-01-01

A Good Practice is a practice that works well, produces good results, and is recommended as a model. MACVIA-ARIA Sentinel Network (MASK), the new Allergic Rhinitis and its Impact on Asthma (ARIA) initiative, is an example of a Good Practice focusing on the implementation of multi-sectoral care

Establishing Good Laboratory Practice at Small Colleges and Universities

Directory of Open Access Journals (Sweden)

Susan Meryl Bornstein-Forst

2017-05-01

Full Text Available Good Laboratory Practice (GLP and Standard Operating Procedures (SOPs provide guidelines for proper operation of equipment, maintenance and sanitation, reporting structures, and related activities. These practices are routinely employed at large academic and research-based institutions. However, they are often overlooked or omitted at smaller colleges and universities where staff and resources are limited. Incorrect assumptions and presumed responsibilities can lead to safety hazards, damage to equipment, loss of infrastructure, and confusion regarding operations and oversight. This report addresses the development of the “who, what, when, how, and where” policies and SOPs that constitute GLP. Once established and utilized by all departmental members, these structures ensure that academic and research-related activities are conducted safely and efficiently.

Guide to good practices for developing learning objectives. DOE guideline

Energy Technology Data Exchange (ETDEWEB)

1992-07-01

This guide to good practices provides information and guidance on the types of, and the development of learning objectives in performance-based training system at reactor and nonreactor nuclear facilities. Contractors are encouraged to consider this guidance as a reference when developing new learning objectives or refining existing ones. Training managers, designers, developers, and instructors are the intended audiences.

Going GLP: Conducting Toxicology Studies in Compliance with Good Laboratory Practices.

Science.gov (United States)

Carroll, Erica Eggers

2016-01-01

Good laboratory practice standards are US federal regulations enacted as part of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR Part 160), the Toxic Substance Control Act (40 CFR Part 792), and the Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58) to support protection of public health in the areas of pesticides, chemicals, and drug investigations in response to allegations of inaccurate data acquisition. Essentially, good laboratory practices (GLPs) are a system of management controls for nonclinical research studies involving animals to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of data collected as part of chemical (including pharmaceuticals) tests, from in vitro through acute to chronic toxicity tests. The GLPs were established in the United States in 1978 as a result of the Industrial Bio-Test Laboratory scandal which led to congressional hearings and actions to prevent fraudulent data reporting and collection. Although the establishment of infrastructure for GLPs compliance is labor-intensive and time-consuming, achievement and maintenance of GLP compliance ensures the accuracy of the data collected from each study, which is critical for defending results, advancing science, and protecting human and animal health. This article describes how and why those in the US Army Medical Department responsible for protecting the public health of US Army and other military personnel made the policy decision to have its toxicology laboratory achieve complete compliance with GLP standards, the first such among US Army laboratories. The challenges faced and how they were overcome are detailed.

Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures.

Science.gov (United States)

Acquadro, Catherine; Patrick, Donald L; Eremenco, Sonya; Martin, Mona L; Kuliś, Dagmara; Correia, Helena; Conway, Katrin

2017-01-01

This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) undertook the review of several TA approaches, with the collaboration of organizations who are involved in conducting TA, and members of the TCA-SIG. The effort led to agreement by the writing group on Good Practices for 1) the terminology to be used in referring to translatability process, 2) the best definition of TA, 3) the methodology that is recommended at each step of the process, 4) the persons involved in TA, 5) the timing of assessment, 6) the review criteria for TA, and 7) the recommendations to be made at the end of the TA process. With input from the TCA-SIG membership and in consultation with experts in the field, these emerging good practices can guide the future use of TA in the development of PROs.

Technology, International Trade, and Pollution from US Manufacturing

OpenAIRE

Arik Levinson

2009-01-01

Pollution emitted by US manufacturers declined markedly over the past several decades, even as real manufacturing output increased. I first show that most of the decline in US manufacturing pollution has resulted from changing production processes ("technology"), rather than changes in the mix of goods produced. I then show that increased net imports of polluting goods ("international trade") accounts for only a small portion of the pollution reductions from the changing mix of goods. Togethe...

ENVIRONMENTAL RISK ASSESSMENT OF SOME COPPER BASED FUNGICIDES ACCORDING TO THE REQUIREMENTS OF GOOD LABORATORY PRACTICE

Directory of Open Access Journals (Sweden)

Marga GRĂDILĂ

2015-10-01

Full Text Available The paper presents data demonstrating the functionality of biological systems reconstituted with aquatic organisms developed under Good Laboratory Practice testing facility within Research - Development Institute for Plant Protection Bucharest for environmental risk assessment of four fungicides based on copper, according to Good Laboratory Practice requirements. For risk assessment, according to GLP were made the following steps: Good Laboratory Practice test facility was established, we have ensured adequate space for growth, acclimatization and testing for each test species, it was installed a complex water production instalation needed to perform tests, it was achieved control system for checking environmental conditions and have developed specific operating procedures that have been accredited according to Good Laboratory Practice.The results showed that biological systems model of the Good Laboratory Practice test facility in Research - Development Institute for Plant Protection meet the requirements of Organisation for Economic Co-operation and Development Guidelines regarding GLP, and after testing copper-based fungicides in terms of acute toxicity Cyprinus carpio and to Daphnia magna revealed that three of them (copper oxychloride, copper hydroxide and copper sulphate showed ecological efficiency, ie low toxicity. Metallic copper based fungicides showed a higher toxicity, resulting in fish toxicity symptoms: sleep, sudden immersion, faded, weakness, swimming in spiral, lack of balance, breathing slow and cumbersome, spasms and mortality.

Best Manufacturing Practices. Report of Survey Conducted at Stafford County Public Schools, Stafford County, VA

National Research Council Canada - National Science Library

1994-01-01

During the week of August 8, 1994, a Best Manufacturing Practices (BMP) survey was conducted at the Stafford County Public Schools located in Stafford County, Virginia, considered one of the fastest growing counties in the state...

The ESDP and Good Practices of Local Development in Peripheral Areas

DEFF Research Database (Denmark)

Gallina, Andrea; Capecchi, Vittorio

shows that the EU documents concerned with spatial planning and regional development suffer from a strong ambiguity in the choice of the development model (either neoliberal or solidaristic economy) both within Europe and in relation with Third countries. Through the analysis of selected good practices...

Paks shows the way towards good operating practices

International Nuclear Information System (INIS)

Anon.

1989-01-01

The Paks-3 unit in Hungary was the first VVER (Soviet designed Pressurized Water Reactor) to be scrutinized by an International Atomic Energy Agency Operational Safety Analysis Review Team. A number of examples of good operational practice were noted. Those reported here include the cleanliness of the plant, the management attitude to training, early detection of and action to correct problems as they arise, an accident avoidance policy, a back-up research and development programme, and the provision of computer-based assistance to the operator to present operational data in an easily comprehensible form. (U.K.)

Procedures development and methodology of control for application of good manufacture practices (GMP) on human blood irradiation; Desenvolvimento de procedimentos e metodologia de controle para aplicacao de boas praticas de fabricacao (BPF) na irradiacao de sangue humano

Energy Technology Data Exchange (ETDEWEB)

Boghi, Claudio

2008-07-01

The irradiation of human blood is used to avoid the TA-GVHD (transfusion-associated graft-versus-host-disease), a rare but devastating adverse effect of leukocytes present in blood components for a immunocompetent transfusion recipients. Usually this irradiation practice is performed to a physical elimination of leukocytes. The implementation of the procedures will assure that the properly dose in a range of 25 Gy to 50 Gy will be delivered to the blood in the bag collected in a blood tissue bank. The studies of the procedures in order to establish a GMP (Good Manufacturing Practices) were developed under the guidelines of the standard ISO 11137 - Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization. In this work, two dosimetric systems were used for dose mapping during the studies of irradiator qualification, loading pattern, irradiation process validation and auditing. The CaS0{sub 4}:Dy dosimeter presented difficulties concerning to uncertainty on dose measurement, stability, traceability and calibration. The PMMA and Gafchromic dosimetric systems have shown a better performance and were adopted on studies of irradiators qualification that are necessary to implementation of GMP. The irradiation tests have been done in a Gammacell 220 irradiator. The developed procedures can be adapted for different kinds of gamma irradiators, allowing implanting a quality assurance program and a GMP for blood irradiation. (author)

Business models for additive manufacturing

DEFF Research Database (Denmark)

Hadar, Ronen; Bilberg, Arne; Bogers, Marcel

2015-01-01

Digital fabrication — including additive manufacturing (AM), rapid prototyping and 3D printing — has the potential to revolutionize the way in which products are produced and delivered to the customer. Therefore, it challenges companies to reinvent their business model — describing the logic...... of creating and capturing value. In this paper, we explore the implications that AM technologies have for manufacturing systems in the new business models that they enable. In particular, we consider how a consumer goods manufacturer can organize the operations of a more open business model when moving from...... a manufacturer-centric to a consumer-centric value logic. A major shift includes a move from centralized to decentralized supply chains, where consumer goods manufacturers can implement a “hybrid” approach with a focus on localization and accessibility or develop a fully personalized model where the consumer...

Adaptive governance good practice: Show me the evidence!

Science.gov (United States)

Sharma-Wallace, Lisa; Velarde, Sandra J; Wreford, Anita

2018-09-15

-based adaptive governance good practice within and across diverse sectors, issues, and contexts. Copyright © 2018. Published by Elsevier Ltd.

A guide for good practices in medical physics - French Society of Medical Physics

International Nuclear Information System (INIS)

Rosenwald, Jean-Claude; Aventin, Christophe; Coste, Frederic; Francois, Pascal; Ginestet, Chantal; Perrin, Benedicte; Salvat, Cecile; Caselles, Olivier; Dedieu, Veronique; Dejean, Catherine; Batalla, Alain; Guillaume, Bonniaud; LeDu, Dominique; Lisbona, Albert; Marchesi, Vincent; Sarrazin, Thierry; Mazeron, Jean-Jacques; Lipinski, Francis; Vera, Pierre; Maximilien Vermandel; Ducou le Pointe, Hubert; Vidal, Vincent; Henry, Cecile; Mazeau-Woynar, Valerie; Prot, Camille; Valero, Marc; Aubert, Bernard; Etard, Cecile; Jimonet, Christine; Roue, Amelie; Sage, Julie; Bardies, Manuel; Beauvais, Helene; Bey, Pierre; Costa, Andre; Desblancs, Claire; Eudaldo, Teresa; Farman, Bardia; Ferrand, Regis; Garcia, Robin; Giraud, Jean-Yves; Husson, Francois; Koulibaly, Malick; Carlan, Loic de; Manens, Jean-Pierre; Naudy, Suzanne; Noel, Alain; Pilette, Pierre; Verdun, Francis

2012-12-01

After a presentation of the methodological approach used to write this book, the first chapter addresses the profession of medical physicist: medical physics in France (history, evolution of the profession, of the education and of regulation), legal framework (related to the medical use of ionizing radiations, legal texts directly concerning medical physics, regulations impacting the professional practice of medical physicists), scopes of intervention of the medical physicist (context, missions, dose management, image quality, quality management and safety, relationship with the patient, education, training and research, relationships with industry, cost management), operating conditions, and good professional practices. The second chapter addresses the principles of management of quality and safety: quality management in medical physics, safety management, quality and safety in health care facilities. The third part addresses good practices in medical physics: general principles of working methods, equipment management, participation to clinic activities

Oman. Quality Culture in Higher Education A Good-Practice Example

Directory of Open Access Journals (Sweden)

Nicola Huson

2015-10-01

Diesem Ansatz folgend liefert die folgende Reflektion zu der Entwicklung einer Lehrendeninitiative an der German University of Technology in Oman ein Good-Practice-Beispiel für die Förderung einer Qualitätskultur innerhalb einer Hochschulinstitution. Diese erfolgt unter Berücksichtigung der soziokulturellen, institutionellen und initiative-bezogenen Rahmenbedingungen und verifiziert das Beispiel innerhalb eines theoretischen Qualitätskulturmodells.

Dietary supplement good manufacturing practices: preparing for compliance

National Research Council Canada - National Science Library

Mead, William J

2012-01-01

.... Based on broad experience with GMP compliance techniques worked out over the years in the food, drug, and medical device industries, it is a must-have guide for all DS companies, especially the many...

Liberal Arts Colleges and Good Practices in Undergraduate Education: Additional Evidence

Science.gov (United States)

Seifert, Tricia A.; Pascarella, Ernest T.; Goodman, Kathleen M.; Salisbury, Mark H.; Blaich, Charles F.

2010-01-01

Liberal arts colleges have prided themselves on providing students with a quality undergraduate education among a scholarly community who are interested in their holistic development. Past research has found students who attended liberal arts colleges more frequently experienced Chickering and Gamson's (1987, 1991) good practices in undergraduate…

Good practices of publishing AYUSH research: A practical checklist for authors

Directory of Open Access Journals (Sweden)

Kishor Patwardhan

2017-04-01

Full Text Available Since its inception, Journal of Ayurveda and Integrative Medicine (J-AIM has been constantly striving to create an environment that inculcates and strengthens “Good Publication Practices (GPP” amongst students, practitioners and researchers in AYUSH community. The J-AIM has been doing this in the form of conducting workshops on scientific writing and research methods on different platforms. This article is based on our experiences and varied discussions that we have had with students, teachers, practitioners and researchers during these interactive sessions, and is intended at addressing the gap that prevails in the domain. The need for such awareness is felt even more strongly ever since the Beall's list of predatory journals has been unpublished. This article tries to fill the void this disappearance has created. We analyze the current scenario of AYUSH publications, enumerate the common perceptions and concerns among the workers in the field, and consider the periodicals where the doctoral and postgraduate level of Ayurveda research works are being published at present. The article also presents a practical checklist that will be helpful for students and teachers to refer authentic resources and submit their work to an appropriate scholarly journal.

Guide to good practices for operations aspects of unique processes

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-12-01

This Guide to Good Practices is written to enhance understanding of, and provide direction for, Operations Aspects of Facility Chemistry and Unique Processes, Chapter XIII of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing employee training and facility management programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Operations Aspects of Unique Processes is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for all personnel to coordinate interrelated activities affecting unique processes.

Silica dust control in small-scale building/structure demolition operations using good work practice guidance

International Nuclear Information System (INIS)

Muianga, C V; Rice, C H; Succop, P

2009-01-01

Work practices can influence exposure, especially in small-scale operations conducted by mobile work crews. This study evaluated the use of information on good work practice in control guidance sheets adapted from UK Silica Essentials guidance sheets by trained workers and supervisors employed in small-scale concrete and masonry demolition operations. A one-page employee silica task-based control guidance sheet for each of four demolition tasks and multiple-page silica control guidance for supervisors were developed. Interactive, hands-on worker training on these task-based good work practice controls was developed. Training was presented to 26 participants from two demolition crews. Feedback on the training and task-based good work practice control guidance sheets was elicited. Observations of work practices were made before and after training. Participants indicated gains in knowledge and checklists were used to document skill attainment. The quality of the training and usefulness of the material/skills was rated high by trainees. Increased use of water to suppress dust and wet cleaning methods on the job were documented following the training. Additional follow-up after training is required to determine long-term impact on sustained changes in work practices, and to evaluate the need for refresher training.

Silica dust control in small-scale building/structure demolition operations using good work practice guidance

Science.gov (United States)

Muianga, C. V.; Rice, C. H.; Succop, P.

2009-02-01

Work practices can influence exposure, especially in small-scale operations conducted by mobile work crews. This study evaluated the use of information on good work practice in control guidance sheets adapted from UK Silica Essentials guidance sheets by trained workers and supervisors employed in small-scale concrete and masonry demolition operations. A one-page employee silica task-based control guidance sheet for each of four demolition tasks and multiple-page silica control guidance for supervisors were developed. Interactive, hands-on worker training on these task-based good work practice controls was developed. Training was presented to 26 participants from two demolition crews. Feedback on the training and task-based good work practice control guidance sheets was elicited. Observations of work practices were made before and after training. Participants indicated gains in knowledge and checklists were used to document skill attainment. The quality of the training and usefulness of the material/skills was rated high by trainees. Increased use of water to suppress dust and wet cleaning methods on the job were documented following the training. Additional follow-up after training is required to determine long-term impact on sustained changes in work practices, and to evaluate the need for refresher training.

Healthcare associated infection: good practices, knowledge and the locus of control in heatlhcare professionals.

Science.gov (United States)

Taffurelli, Chiara; Sollami, Alfonso; Camera, Carmen; Federa, Francesca; Grandi, Annise; Marino, Marcella; Marrosu, Tiziano; Sarli, Leopoldo

2017-07-18

  The incidence of Healthcare Associated Infections (HAI) is an important indicator of the quality of care. The behaviors associated with the prevention of infections are not only supported by rational knowledge or motivation, but are mediated by social, emotional and often stereotyped behaviors. The awarness of the good practices related to HAI, may be a factor. Other studies, identify how the perception of the problem in healthcare professionals is often influenced by a tendency towards an external Locus of Control: the patient, the family, the other wards, other care settings. The aim of this study is to investigate the perception of healthcare professionals. In particular they have been measured their  awarness of the good practices, perceptions of the potential contamination level of some commonly used objects, knowledge about the management of invasive devices, Locus of Control.   A cross-sectional correlational design was utilized.  An ad hoc questionnaire was interviewed by 222 health professionals nurses and physicians in a northern hospital of Italy. The percentage of professionals who have attended training courses over the last 5 years was quite high, both for upgrades on HAI (78.7%) and Vascular Catheters (78.8%), while the percentage of professionals who updated on bladder catheterization (59.46%) was lower. The mean  score of good practice awareness towards HAI (5.06), is high. The perception of the potential level of contamination of some devices had a  mean ranging from 4.62 (for the drip) to 5.26 (for the door handle). The average value of the Locus of Control (43.54) indicates that participants demonstrated a value that is midway between External and Internal. The correlation test analysis revealed no significant relationships among professionals'age, knowledge about HAI, or infection related venus catheter. Also, results revealed that there were statistically significant positive relationships between professionals' Good Practices

Identification of Good Practices in the Implementation of Innovative Learning Methodologies

Science.gov (United States)

Lincaru, Cristina; Ciuca, Vasilica; Grecu, Liliana; Atanasiu, Draga; Dragoiu, Codruta

2011-01-01

We intend to present the partial issues resulted from the development of the European Project DeInTRA "cooperation for innovative training methodologies deployment in the European Labour Market"--Stage 4: Identification of good practices in the implementation of innovative learning methodologies. This project is included into the…

Values Education as Good Practice Pedagogy: Evidence from Australian Empirical Research

Science.gov (United States)

Lovat, Terence

2017-01-01

This article focuses on the Australian Government's Values Education Program and, within its context, the "Values Education Good Practice Schools Project" (VEGPSP) Reports and the "Project to Test and Measure the Impact of Values Education on Student Effects and School Ambience," funded federally from 2003 to 2010. Findings…

The relationship among the resiliency practices in supply chain, financial performance, and competitive advantage in manufacturing firms in Indonesia and Sierra Leone

Science.gov (United States)

Musa, I.; Nyoman Pujawan, I.

2018-04-01

Current supply chain management (SCM) has become a potentially treasured way of safeguarding competitive advantage and improving organizational performance since competition is no longer between organizations, but among supply chains. This research conceptualizes and develops four resiliency practices (Flexibility, Redundancy, Collaboration and Agility) and tests the relationships between organizations’ financial performance and competitive advantage in manufacturing firms. The study involves manufacturing firms in Indonesia and Sierra Leone. The study used stratified random sampling to pick a sample size of 95 manufacturing firms, which represented different industrial sectors. The respondents were mainly managers of different manufacturing companies. The relationships proposed in the conceptual framework were tested using correlation analysis. The results indicate that higher levels of resilience practices in manufacturing firms can lead to enhanced competitive advantage and improved financial performance.

Basic model of quality and good practices in neonatal radiography

International Nuclear Information System (INIS)

Dias, Janine H.; Goulart, Juliana M.; Lykawka, Rochelle; Bacelar, Alexandre

2016-01-01

Neonatal chest radiographs were evaluated and 3 variables were analyzed: collimation, positioning and presence of artifacts. This study is a pilot for develop a model of good practices in radiology, which is in development phase. The index of analyzed radiographs considered inadequate is expressive and it shows the need for a model that may be part of an optimization program to medical exposures. (author)

Good practices in radiological protection at Narora Atomic Power Station

International Nuclear Information System (INIS)

Singh, V.P.; Kumar, Sanjeev; Agrawal, Mitesh; Tiwari, S.K.; Kulhari, Praveen; Gupta, Ashok

2016-01-01

Radiological protection performance of nuclear power plant is assessed by collective exposure, individual average exposure, external/external exposure, personnel/surface contamination and reduction of radioactive wastes. Collective exposure is reduced by integrated comprehensive ALARA program in all aspects of nuclear plant operation and maintenance has reduced collective dose many folds. In the present paper, implementation of new good practices in Radiological Protection is presented

Good Practice Guide Waste Minimization/Pollution Prevention; TOPICAL

International Nuclear Information System (INIS)

J Dorsey

1999-01-01

This Good Practice Guide provides tools, information, and examples for promoting the implementation of pollution prevention during the design phases of U.S. Department of Energy (DOE) projects. It is one of several Guides for implementing DOE Order 430.1, Life-cycle Asset Management. DOE Order 430.1 provides requirements for DOE, in partnership with its contractors, to plan, acquire, operate, maintain, and dispose of physical assets. The goals of designing for pollution prevention are to minimize raw material consumption, energy consumption, waste generation, health and safety impacts, and ecological degradation over the entire life of the facility (EPA 1993a). Users of this Guide will learn to translate national policy and regulatory requirements for pollution prevention into action at the project level. The Guide was written to be applicable to all DOE projects, regardless of project size or design phase. Users are expected to interpret the Guide for their individual project's circumstances, applying a graded approach so that the effort is consistent with the anticipated waste generation and resource consumption of the physical asset. This Guide employs a combination of pollution prevention opportunity assessment (PPOA) methods and design for environment (DfE) philosophies. The PPOA process was primarily developed for existing products, processes, and facilities. The PPOA process has been modified in this Guide to address the circumstances of the DOE design process as delineated in DOE Order 430.1 and its associated Good Practice Guides. This modified form of the PPOA is termed the Pollution Prevention Design Assessment (P2DA). Information on current nationwide methods and successes in designing for the environment also have been reviewed and are integrated into this guidance

Deterring Violent Extremism in America by Utilizing Good Counter-Radicalization Practices from Abroad: A Policy Perspective

Science.gov (United States)

2017-03-01

counter-violent extremism, deterring violent extremism, counter-radicalization, country study, CVE, DVE, deterrence, policy perspective , good practices...both North America and in Europe, more constructive policies must be developed to manage diversity. There are serious flaws in the current policies...EXTREMISM IN AMERICA BY UTILIZING GOOD COUNTER-RADICALIZATION PRACTICES FROM ABROAD: A POLICY PERSPECTIVE by Amy Fires Bonanno March 2017

IMPACT OF THE FOREIGN DIRECT INVESTMENT FROM THE MANUFACTURING SECTOR ON THE ROMANIAN IMPORTS OF INTERMEDIATE GOODS AND OF RAW MATERIALS

Directory of Open Access Journals (Sweden)

RAMONA DUMITRIU

2010-01-01

Full Text Available Increasing exports by stimulating the foreign direct investment could be a solution to the problem of the persistent trade balance deficit of Romania. However, in such an attempt there have to be taken into consideration the potential effects of the foreign direct investment on some categories of imports. This paper explores the dynamic relation between the foreign direct investment from the manufacturing sector and the Romanian imports of intermediate goods and raw materials. We found causality linkages between the foreign direct investment and the imports of intermediate goods, meaning that Romanian branches of the multinational companies prefer to import such goods instead of producing or buying from the domestic markets. Instead, we failed to identify any causality between the foreign direct investment and the imports of raw materials.

Precision manufacturing

CERN Document Server

Dornfeld, David

2008-01-01

Today there is a high demand for high-precision products. The manufacturing processes are now highly sophisticated and derive from a specialized genre called precision engineering. Precision Manufacturing provides an introduction to precision engineering and manufacturing with an emphasis on the design and performance of precision machines and machine tools, metrology, tooling elements, machine structures, sources of error, precision machining processes and precision process planning. As well as discussing the critical role precision machine design for manufacturing has had in technological developments over the last few hundred years. In addition, the influence of sustainable manufacturing requirements in precision processes is introduced. Drawing upon years of practical experience and using numerous examples and illustrative applications, David Dornfeld and Dae-Eun Lee cover precision manufacturing as it applies to: The importance of measurement and metrology in the context of Precision Manufacturing. Th...

Supply chain design approaches for supply chain resilience: A qualitative study of South African fast-moving consumer goods grocery manufacturers

Directory of Open Access Journals (Sweden)

Assilah Agigi

2016-10-01

Full Text Available Orientation: In today’s globalised and complex business environment, firms are ever more vulnerable to supply chain disruptions, originating both internally and externally from the supply chain. Supply chain resilience minimises the impact of a disruption through design approaches, which allows the supply chain to respond appropriately to disruptive events. Research purpose: This article investigated the supply chain risks faced by grocery manufacturers in the South African fast-moving consumer goods (FMCG industry and explored supply chain design approaches that enable supply chain resilience. Motivation for the study: South African grocery manufacturers are faced with distinct risks. Whilst supply chain risk management studies have provided firms with certain guidelines to mitigate risk, supply chains are still vulnerable to unanticipated risks. Literature on supply chain resilience in the South African context is scant. The concept of supply chain resilience provides firms with strategies that are built into the supply chain that allow firms to react and recover swiftly from disruptions. Furthermore, supply chain resilience strategies assist firms in becoming less vulnerable to possible disruptions. Research design approach and method: This study was conducted by using a descriptive qualitative research design. Data were collected through semi-structured interviews with senior supply chain practitioners specifically within the South African FMCG grocery manufacturing industry. Main findings: The study found that labour unrest is the most common risk faced by the industry. Furthermore, strategic stock and supply chain mapping are of the most useful design approaches to enhance supply chain resilience. Practical/managerial implications: The study provides managers with new insights in guiding supply chain design decisions for resilient supply chains. Through the identification of risks and appropriate solutions linked to the various risks

A Rapid Assessment Tool for affirming good practice in midwifery education programming.

Science.gov (United States)

Fullerton, Judith T; Johnson, Peter; Lobe, Erika; Myint, Khine Haymar; Aung, Nan Nan; Moe, Thida; Linn, Nay Aung

2016-03-01

to design a criterion-referenced assessment tool that could be used globally in a rapid assessment of good practices and bottlenecks in midwifery education programs. a standard tool development process was followed, to generate standards and reference criteria; followed by external review and field testing to document psychometric properties. review of standards and scoring criteria were conducted by stakeholders around the globe. Field testing of the tool was conducted in Myanmar. eleven of Myanmar׳s 22 midwifery education programs participated in the assessment. the clinimetric tool was demonstrated to have content validity and high inter-rater reliability in use. a globally validated tool, and accompanying user guide and handbook are now available for conducting rapid assessments of compliance with good practice criteria in midwifery education programming. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Good quantification practices of flavours and fragrances by mass spectrometry.

Science.gov (United States)

Begnaud, Frédéric; Chaintreau, Alain

2016-10-28

Over the past 15 years, chromatographic techniques with mass spectrometric detection have been increasingly used to monitor the rapidly expanded list of regulated flavour and fragrance ingredients. This trend entails a need for good quantification practices suitable for complex media, especially for multi-analytes. In this article, we present experimental precautions needed to perform the analyses and ways to process the data according to the most recent approaches. This notably includes the identification of analytes during their quantification and method validation, when applied to real matrices, based on accuracy profiles. A brief survey of application studies based on such practices is given.This article is part of the themed issue 'Quantitative mass spectrometry'. © 2016 The Authors.

A Holistic Approach to Estimating the Influence of Good Practices on Student Outcomes at Liberal Arts and non-Liberal Arts Institutions

Directory of Open Access Journals (Sweden)

Brian P. An

2016-04-01

Full Text Available Many higher education administrators and researchers have considered certain “good practices” of institutions as an instrumental way to improve student outcomes. Chickering and Gamson’s (1987 seven principles of good practice has been particularly salient in defining these practices. Often, prior studies only select some of the seven principles for their analysis. Even studies that consider several principles of good practice on student outcomes typically examine the net effect of each principle instead of assessing how these principles holistically influence student outcomes. Using structural equation modeling, we test a basic conceptual framework where we investigate the contribution of the seven principles on a global measure of good practices (GP, as well as the influence of GP on a multitude of student outcomes. We further test whether liberal arts colleges promote an institutional ethos of good practices as compared to non-liberal arts colleges. Overall, the majority (but not all of the principles affect GP. Moreover, we find partial evidence that liberal arts colleges foster an institutional ethos of good practices. Although a commitment to foster good practices may create a supportive environment that influences student outcomes, this commitment may lead to unintended consequences for those with little exposure to these good practices.

Examples of Holistic Good Practices in Promoting and Protecting Mental Health in the Workplace: Current and Future Challenges.

Science.gov (United States)

Sivris, Kelly C; Leka, Stavroula

2015-12-01

While attention has been paid to physical risks in the work environment and the promotion of individual employee health, mental health protection and promotion have received much less focus. Psychosocial risk management has not yet been fully incorporated in such efforts. This paper presents good practices in promoting mental health in the workplace in line with World Health Organization (WHO) guidance by identifying barriers, opportunities, and the way forward in this area. Semistructured interviews were conducted with 17 experts who were selected on the basis of their knowledge and expertise in relation to good practice identified tools. Interviewees were asked to evaluate the approaches on the basis of the WHO model for healthy workplaces. The examples of good practice for Workplace Mental Health Promotion (WMHP) are in line with the principles and the five keys of the WHO model. They support the third objective of the WHO comprehensive mental health action plan 2013-2020 for multisectoral implementation of WMHP strategies. Examples of good practice include the engagement of all stakeholders and representatives, science-driven practice, dissemination of good practice, continual improvement, and evaluation. Actions to inform policies/legislation, promote education on psychosocial risks, and provide better evidence were suggested for higher WMHP success. The study identified commonalities in good practice approaches in different countries and stressed the importance of a strong policy and enforcement framework as well as organizational responsibility for WMHP. For progress to be achieved in this area, a holistic and multidisciplinary approach was unanimously suggested as a way to successful implementation.

Top management and the adoption of energy efficiency practices: Evidence from small and medium-sized manufacturing firms in the US

International Nuclear Information System (INIS)

Blass, Vered; Corbett, Charles J.; Delmas, Magali A.; Muthulingam, Suresh

2014-01-01

Barriers to energy efficiency have been extensively discussed in the energy literature, but little is known about positive drivers. This paper investigates the role of top managers and more specifically of top operations managers on the adoption of energy-efficiency practices, based on 5779 energy efficiency recommendations made to 752 small and medium-sized manufacturing firms under the US Department of Energy's IACs (Industrial Assessment Centers) Program, through which teams of students and faculty from engineering schools provide free energy assessments. Top operations managers possess knowledge of production processes, for maximizing the effective manufacture and distribution of goods. We find that their involvement significantly increases the adoption of energy-efficiency initiatives, while involvement of general top managers without an operational role has little or no effect. Involvement of top operations managers increases the percentage of recommended energy savings that are implemented by 13.4% on average and increases the probability of adoption of more disruptive individual recommendations related to process and equipment change from 31% to 44%. Our findings imply that, in order to advance energy efficiency in SMEs (Small and Medium Enterprises), it may be advisable to target managers who are sufficiently senior but still in a clearly operationally-focused position. - Highlights: • We examine how top managers influence the adoption of energy-efficiency practices. • Top operations managers implement 13.4% more of recommended savings. • Involvement of top managers without an operational role has little or no effect. • Top operations managers enhance adoption of recommendations that are disruptive

Police Enforcement Policy and Programmes on European Roads (PEPPER). Workpackage WP4 `Good Practices in Traffic Enforcement', Working paper 24: Good practice in data and data collection for monitoring and evaluating traffic law enforcement.

NARCIS (Netherlands)

Schagen, I.N.L.G. van Bernhoft, I.M. Erke, A. Ewert, U. Kallberg, V.-P. & Skladana, P.

2007-01-01

This working paper describes the good practice requirements regarding data and data collection for monitoring and evaluating Traffic Law Enforcement (TLE). The aim is at, eventually, individual police forces/countries put the identified ’good practice’ data into a European TLE monitoring database

Commentary on the MID3 Good Practices Paper.

Science.gov (United States)

Manolis, Efthymios; Brogren, Jacob; Cole, Susan; Hay, Justin L; Nordmark, Anna; Karlsson, Kristin E; Lentz, Frederike; Benda, Norbert; Wangorsch, Gaby; Pons, Gerard; Zhao, Wei; Gigante, Valeria; Serone, Francesca; Standing, Joseph F; Dokoumetzidis, Aris; Vakkilainen, Juha; van den Heuvel, Michiel; Mangas Sanjuan, Victor; Taminiau, Johannes; Kerwash, Essam; Khan, David; Musuamba, Flora Tshinanu; Skottheim Rusten, Ine

2017-07-01

During the last 10 years the European Medicines Agency (EMA) organized a number of workshops on modeling and simulation, working towards greater integration of modeling and simulation (M&S) in the development and regulatory assessment of medicines. In the 2011 EMA - European Federation of Pharmaceutical Industries and Associations (EFPIA) Workshop on Modelling and Simulation, European regulators agreed to the necessity to build expertise to be able to review M&S data provided by companies in their dossier. This led to the establishment of the EMA Modelling and Simulation Working Group (MSWG). Also, there was agreement reached on the need for harmonization on good M&S practices and for continuing dialog across all parties. The MSWG acknowledges the initiative of the EFPIA Model-Informed Drug Discovery and Development (MID3) group in promoting greater consistency in practice, application, and documentation of M&S and considers the paper is an important contribution towards achieving this objective. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Health physics manual of good practices for plutonium facilities. [Contains glossary

Energy Technology Data Exchange (ETDEWEB)

Brackenbush, L.W.; Heid, K.R.; Herrington, W.N.; Kenoyer, J.L.; Munson, L.F.; Munson, L.H.; Selby, J.M.; Soldat, K.L.; Stoetzel, G.A.; Traub, R.J.

1988-05-01

This manual consists of six sections: Properties of Plutonium, Siting of Plutonium Facilities, Facility Design, Radiation Protection, Emergency Preparedness, and Decontamination and Decommissioning. While not the final authority, the manual is an assemblage of information, rules of thumb, regulations, and good practices to assist those who are intimately involved in plutonium operations. An in-depth understanding of the nuclear, physical, chemical, and biological properties of plutonium is important in establishing a viable radiation protection and control program at a plutonium facility. These properties of plutonium provide the basis and perspective necessary for appreciating the quality of control needed in handling and processing the material. Guidance in selecting the location of a new plutonium facility may not be directly useful to most readers. However, it provides a perspective for the development and implementation of the environmental surveillance program and the in-plant controls required to ensure that the facility is and remains a good neighbor. The criteria, guidance, and good practices for the design of a plutonium facility are also applicable to the operation and modification of existing facilities. The design activity provides many opportunities for implementation of features to promote more effective protection and control. The application of ''as low as reasonably achievable'' (ALARA) principles and optimization analyses are generally most cost-effective during the design phase. 335 refs., 8 figs., 20 tabs.

Factors associated with good TB infection control practices among primary healthcare workers in the Free State Province, South Africa.

Science.gov (United States)

Engelbrecht, Michelle; Janse van Rensburg, André; Kigozi, Gladys; van Rensburg, Hcj Dingie

2016-11-04

Despite the availability of TB infection control guidelines, and good levels of healthcare worker knowledge about infection control, often these measures are not well implemented. This study sought to determine the factors associated with healthcare workers' good TB infection control practices in primary health care facilities in the Free State Province, South Africa. A cross-sectional self-administered survey among nurses (n = 202) and facility-based community healthcare workers (n = 34) as well as facility observations were undertaken at all 41 primary health care facilities in a selected district of the Free State Province. The majority of respondents were female (n = 200; 87.7 %) and the average age was 44.19 years (standard deviation ±10.82). Good levels of knowledge were recorded, with 42.8 % (n = 101) having an average score (i.e. 65-79 %) and 31.8 % (n = 75) a good score (i.e. ≥ 80 %). Most respondents (n = 189; 80.4 %) had positive attitudes towards TB infection control practices (i.e. ≥ 80 %). While good TB infection control practices were reported by 72.9 % (n = 161) of the respondents (i.e. ≥75 %), observations revealed this to not necessarily be the case. For every unit increase in attitudes, good practices increased 1.090 times (CI:1.016-1.169). Respondents with high levels of knowledge (≥80 %) were 4.029 (CI: 1.550-10.469) times more likely to have good practices when compared to respondents with poor levels of knowledge (control were the main factors associated with good infection control practices. Although many respondents reported good infection control practices - which was somewhat countered by the observations - there are areas that require attention, particularly those related to administrative controls and the use of personal protective equipment.

Design and Evaluation of a Reconfigurable Manufacturing System

DEFF Research Database (Denmark)

Zhang, Shuai; Li, Yang; Bilberg, Arne

2014-01-01

In modern manufacturing industry, reconfigurable manufacturing system (RMS) is a promising concept in the research arena. A new RMS system structure has been recently designed by a large consumer goods manufacturer in Europe, aiming to improve its production efficiency. This article shows...... implemented in this consumer goods manufacturer can be effectively (re)configured as part of the daily operations, and the configuration is analyzed by computer simulation before release. Flexibility can be increased considerably meanwhile the system can maintain an acceptable productivity....

Monitoring of good practices programs and independence for electricity and natural gas system operators. Report 2012

International Nuclear Information System (INIS)

2013-09-01

Electricity and natural gas transmission system operators (TSO) and distribution system operators (DSO) are regulated operators that provide public service functions for the benefit of the network users and the consumers they serve. Accordingly, European and French law requires that they be under independent and nondiscriminatory obligations. In particular, they must develop a good practices program which includes a range of measures to prevent the risk of discriminatory practices in network access. Pursuant to Article L.134-15 of the Energy Code, the Energy Regulatory Commission (CRE) is publishing this year its 8. annual report on the monitoring of good practices programs and independence for electricity and natural gas system operators for the year 2012. This report is based on analysis of the 'reports on the implementation of good practices programs' submitted to the CRE by the operators in late 2012 and audits carried out by the CRE services in these companies in 2012

Monitoring of good practices programs and independence for electricity and natural gas system operators. 2010 report

International Nuclear Information System (INIS)

2011-01-01

Electricity and natural gas transmission system operators (TSO) and distribution system operators (DSO) are regulated operators that provide public service functions for the benefit of the network users and the consumers they serve. Accordingly, European and French law requires that they be under independent and nondiscriminatory obligations. In particular, they must develop a good practices program which includes a range of measures to prevent the risk of discriminatory practices in network access. Pursuant to Article L.134-15 of the Energy Code, the Energy Regulatory Commission (CRE) is publishing this year its 6. annual report on the monitoring of good practices programs and independence for electricity and natural gas system operators for the year 2010. This report is based on analysis of the 'reports on the implementation of good practices programs' submitted to the CRE by the operators in late 2010 and audits carried out by the CRE services in these companies in 2010

Good practices of publishing AYUSH research: A practical checklist for authors.

Science.gov (United States)

Patwardhan, Kishor; Tillu, Girish; Jadhav, Priyanka M

Since its inception, Journal of Ayurveda and Integrative Medicine (J-AIM) has been constantly striving to create an environment that inculcates and strengthens "Good Publication Practices (GPP)" amongst students, practitioners and researchers in AYUSH community. The J-AIM has been doing this in the form of conducting workshops on scientific writing and research methods on different platforms. This article is based on our experiences and varied discussions that we have had with students, teachers, practitioners and researchers during these interactive sessions, and is intended at addressing the gap that prevails in the domain. The need for such awareness is felt even more strongly ever since the Beall's list of predatory journals has been unpublished. This article tries to fill the void this disappearance has created. We analyze the current scenario of AYUSH publications, enumerate the common perceptions and concerns among the workers in the field, and consider the periodicals where the doctoral and postgraduate level of Ayurveda research works are being published at present. The article also presents a practical checklist that will be helpful for students and teachers to refer authentic resources and submit their work to an appropriate scholarly journal. Copyright © 2017 Transdisciplinary University, Bangalore and World Ayurveda Foundation. Published by Elsevier B.V. All rights reserved.

Implementation of VOC source reduction practices in a manufactured house and in school classrooms

International Nuclear Information System (INIS)

Hodgson, A.T.; Apte, M.G.; Shendell, D.G.; Beal, D.; McIlvaine, J.E.R.

2002-01-01

Detailed studies of a new manufactured house and four new industrialized relocatable school classrooms were conducted to determine the emission sources of formaldehyde and other VOCs and to identify and implement source reduction practices. Procedures were developed to generate VOC emission factors that allowed reasonably accurate predictions of indoor air VOC concentrations. Based on the identified sources of formaldehyde and other aldehydes, practices were developed to reduce the concentrations of these compounds in new house construction. An alternate ceiling panel reduced formaldehyde concentrations in the classrooms. Overall, the classrooms had relatively low VOC concentrations

Good practice achievement of the firms within National agro processing industry of Thailand: Impacts on corporate image and stakeholder acceptance

Directory of Open Access Journals (Sweden)

Nuttavong Poonpool

2016-07-01

Full Text Available This article is about the effects of good practice achievement on stakeholder acceptance. The study examines the relationship between good practice achievement and stakeholder acceptance, where corporate image is taken as a mediator. The samples were 486 chief executive officers (CEO who participated in the national agro processing industry of Thailand. The ordinary least squares (OLS regression analysis was employed for data analysis. The findings show that good practice achievement, in which consists of fairness, transparency, accountability, responsibility, consistency, and independent, have the positive effect on corporate image significantly (p<0.1. Interestingly, corporate image mediates the relationship between good practice achievement and stakeholder acceptance significantly (p<0.05. Therefore, a key decision for managers in all levels and functions is to focus on good practice achievement that improves and develops corporate image and boost stakeholder acceptance.

INNOVATIONS IN POLISH SOCIAL ECONOMY. GOOD PRACTICES CAFE-BOOKSTORE ''COOPERATIVE”

OpenAIRE

Piotr Krośniak; Anna Szadkowska-Ciężka; Katarzyna Zabratańska

2012-01-01

The article is concentrating on the issue of the social economy and the presentation of good practice from Poland. For elaborating issues an example of the „Cooperative” was used. This is pioneering working on Polish scale which uses innovative actions for the counteraction of social exclusion. Brought up issues are alsoassociated with promotion of creating trilateral partnerships and development of the social franchise model. Presented model is the result of cooperation between UNDP Project ...

Electron beam curing — taking good ideas to the manufacturing floor

Science.gov (United States)

Saunders, C.; Lopata, V.; Barnard, J.; Stepanik, T.

2000-03-01

Acsion is exploiting several emerging electron beam EB applications ranging from composite curing and repair to viscose manufacturing. EB curing of composite structures offers several advantages: significantly reduced curing times; improvements in part quality and performance; reduced environmental and health concerns; improvements in material handling; and reduced overall manufacturing costs compared to thermal curing. The aerospace industry is developing EB technology in all of their market sectors, including military aviation and space products. Some specific products include cryogenic fuel tanks, improved canopy frames for jet aircraft, and the all-composite military aircraft. This paper discusses each of these opportunities.

Guiding principles for good practices in hospital-based health technology assessment units

DEFF Research Database (Denmark)

Sampietro-Colom, Laura; Lach, Krzysztof; Pasternack, Iris

2015-01-01

OBJECTIVES: Health technology assessment (HTA) carried out for policy decision making has well-established principles unlike hospital-based HTA (HB-HTA), which differs from the former in the context characteristics and ways of operation. This study proposes principles for good practices in HB-HTA...

Lean Manufacturing, Mass Customization and their relationships - empirical findings

DEFF Research Database (Denmark)

Christiansen, Thomas Bøhm

2004-01-01

manufacturing companies in 2001-02. This study fills a void in existing research by exploring relationships between bundles of lean manufacturing practices and bundles of mass customization practices. This study is based on a questionnaire that is developed from two existing questionnaires each investigating...... bundles of lean manufacturing practices and bundles of mass customization practices separately. Here, these bundles of practices are related. The results indicate that there are no direct relationships between the lean manufacturing and the mass customization practices, but that the combination of some...... sets of practices can explain differences in performance on important dimensions. The general conclusion, however, is that there are only weak relationships between the two concepts, hence this study suggests that the concepts of lean manufacturing and mass customization at present are more mutually...

[Implementation of good quality and safety practices. Descriptive study in a occupational mutual health centre].

Science.gov (United States)

Manzanera, R; Plana, M; Moya, D; Ortner, J; Mira, J J

2016-01-01

To describe the level of implementation of quality and safety good practice elements in a Mutual Society health centre. A Cross-sectional study was conducted to assess the level of implementation of good practices using a questionnaire. Some quality dimensions were also assessed (scale 0 to 10) by a set of 87 quality coordinators of health centres and a random sample of 54 healthcare professionals working in small centres. Seventy quality coordinators and 27 professionals replied (response rates 80% and 50%, respectively. There were no differences in the assessment of quality attributes between both groups. They identified as areas for improvement: use of practice guidelines (7.6/10), scientific and technical skills (7.5/10), and patient satisfaction (7.7/10). Availability and accessibility to clinical reports, informed consent, availability of hydro-alcoholic solution, and to record allergies, were considered of high importance to be implemented, with training and research, improvements in equipment and technology plans, adherence to clinical practice guidelines and the preparation of risk maps, being of less importance. The good practices related to equipment and resources have a higher likelihood to be implemented, meanwhile those related to quality and safety attitudes have more barriers before being implemented. The mutual has a similar behaviour than other healthcare institutions. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Justification of RFID Implementation. A Case Study of White Goods Manufacturer

Directory of Open Access Journals (Sweden)

Gladysz Bartlomiej

2017-12-01

Full Text Available Radio Frequency Identification (RFID is a rapidly emerging technology with a wide range of impact and still not fully exploited potential applications. The impact of RFID is not limited to the area of its direct application. There are many possible benefits to be gained from RFID application, but it must be preceded with careful analysis as its implementation is not always reasonable. A new method for an assessment of RFID technology was presented and explained on the case of a white goods manufacturer. There was a lack of such a method allowing for relatively quick and flexible assessment, which is important for decision makers, who do not want to become involved in very sophisticated and time-consuming analysis at the early stage of decision making. The method supports early phases of decision making related to RFID implementation. Conclusions derived from the analysis of the case study confirmed that the method applied allows for rationalizing decision making and answers whether RFID could generate strategic advantage, in which area RFID should be applied, how RFID-supported processes will be executed and what benefits would be expected. previous papers focused only on answering specific questions from the above list, without showing a holistic approach. the approach to answer questions about execution of processes and benefits was not considered earlier at all. The paper illustrates details of using a new method of an assessment of RFID technology (ART using a real industrial example.

Introduction to good practice in health, environment and safety management in enterprises

NARCIS (Netherlands)

Baranski, B.; Zwetsloot, G.

2000-01-01

Purpose of this paper, presented on the fifth annual meeting of the Baltic Sea Network on Occupational Health and Safety (Berlin, 18-19 November 1999), is to outline conceptual models of good practice (GP) in Health, Environment and Safety Management in Enterprises (HESME), present major components

Prevention of occupational injuries: Evidence for effective good practices in foundries.

Science.gov (United States)

Porru, Stefano; Calza, Stefano; Arici, Cecilia

2017-02-01

Occupational injuries are a relevant research and practical issue. However, intervention studies evaluating the effectiveness of workplace injury prevention programs are seldom performed. The effectiveness of a multifaceted intervention aimed at reducing occupational injury rates (incidence/employment-based=IR, frequency/hours-based=FR, severity=SR) was evaluated between 2008 and 2013 in 29 Italian foundries (22 ferrous; 7 non-ferrous; 3,460 male blue collar workers/year) of varying sizes. Each foundry established an internal multidisciplinary prevention team for risk assessment, monitoring and prevention of occupational injuries, involving employers, occupational physicians, safety personnel, workers' representatives, supervisors. Targets of intervention were workers, equipment, organization, workplace, job tasks. An interrupted time series (ITS) design was applied. 4,604 occupational injuries and 83,156 lost workdays were registered between 2003 and 2013. Statistical analysis showed, after intervention, a reduction of all injury rates (-26% IR, -15% FR, -18% SR) in ferrous foundries and of SR (-4%) in non-ferrous foundries. A significant (p=0.021) 'step-effect' was shown for IR in ferrous foundries, independent of secular trends (pgood external validity; promotion of effective good practices. Main limitations were the non-randomized nature and a medium length post-intervention period. In conclusion, a multifaceted, pragmatic and accountable intervention is effective in reducing the burden of occupational injuries in small-, medium- and large-sized foundries. Practical Applications: The study poses the basis for feasible good practice guidelines to be implemented to prevent occupational injuries, by means of sector-specific numerical benchmarks, with potentially relevant impacts on workers, companies, occupational health professionals and society at large. Copyright © 2016 National Safety Council and Elsevier Ltd. All rights reserved.

Guide to good practices for on-the-job training

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-04-01

Training programs at DOE facilities should prepare personnel to safely and efficiently operate and maintain the facilities in accordance with DOE requirements. This guide presents good practices for a systematic approach to on-the-job training (OJT) and OJT programs and should be used in conjunction with DOE Training Program Handbook: A Systematic Approach to Training, and with the DOE Handbook entitled Alternative Systematic Approaches to Training to develop performance-based OJT programs. DOE contractors may also use this guide to modify existing OJT programs that do not meet the systematic approach to training (SAT) objectives.

Estimating the harms and benefits of prostate cancer screening as used in common practice versus recommended good practice: A microsimulation screening analysis

NARCIS (Netherlands)

S. Carlsson (Sigrid); T.M. de Carvalho Delgado Marques (Tiago); M.J. Roobol-Bouts (Monique); J. Hugosson (Jonas); A. Auvinen (Anssi); M. Kwiatkowski (Maciej); A. Villers (Arnoud); M. Zappa (Marco); V. Nelen (Vera); A. Páez (Alvaro); J.A. Eastham (James); H. Lilja (Hans); H.J. de Koning (Harry); A.J. Vickers (Andrew); E.A.M. Heijnsdijk (Eveline)

2016-01-01

textabstractBACKGROUND: Prostate-specific antigen (PSA) screening and concomitant treatment can be implemented in several ways. The authors investigated how the net benefit of PSA screening varies between common practice versus “good practice.”. METHODS: Microsimulation screening analysis (MISCAN)

Defense programs beryllium good practice guide

International Nuclear Information System (INIS)

Herr, M.

1997-07-01

Within the DOE, it has recently become apparent that some contractor employees who have worked (or are currently working) with and around beryllium have developed chronic beryllium disease (CBD), an occupational granulomatous lung disorder. Respiratory exposure to aerosolized beryllium, in susceptible individuals, causes an immunological reaction that can result in granulomatous scarring of the lung parenchyma, shortness of breath, cough, fatigue, weight loss, and, ultimately, respiratory failure. Beryllium disease was originally identified in the 1940s, largely in the fluorescent light industry. In 1950, the Atomic Energy Commission (AEC) introduced strict exposure standards that generally curtailed both the acute and chronic forms of the disease. Beginning in 1984, with the identification of a CBD case in a DOE contractor worker, there was increased scrutiny of both industrial hygiene practices and individuals in this workforce. To date, over 100 additional cases of beryllium-specific sensitization and/or CBD have been identified. Thus, a disease previously thought to be largely eliminated by the adoption of permissible exposure standards 45 years ago is still a health risk in certain workforces. This good practice guide forms the basis of an acceptable program for controlling workplace exposure to beryllium. It provides (1) Guidance for minimizing worker exposure to beryllium in Defense Programs facilities during all phases of beryllium-related work, including the decontamination and decommissioning (D ampersand D) of facilities. (2) Recommended controls to be applied to the handling of metallic beryllium and beryllium alloys, beryllium oxide, and other beryllium compounds. (3) Recommendations for medical monitoring and surveillance of workers exposed (or potentially exposed) to beryllium, based on the best current understanding of beryllium disease and medical diagnostic tests available. (4) Site-specific safety procedures for all processes of beryllium that is

Deploying Serious Games for Management in Higher Education: lessons learned and good practices

NARCIS (Netherlands)

Baalsrud Hauge, Jannicke; Bellotti, Francesco; Nadolski, Rob; Kickmeier-Rust, Michael; Berta, Riccardo; Carvalho, Maria B.

2013-01-01

Baalsrud Hauge, J., Bellotti, F., Nadolski, R. J., Kickmeier-Rust, M., Berta, R., & Carvalho, M. B. (2013, 4 October). Deploying Serious Games for Management in Higher Education: lessons learned and good practices. Presentation at ECGBL 2013, Porto, Portugal.

Guide of good practices for methanization projects

International Nuclear Information System (INIS)

Delatte, Constant; Orozco-Souel, Paola; Rouxel, Anaick; Tanneau, Patrick; Schreiber, Konrad; Jaubert, Jean Noel; Micone, Philippe; Dionne, Denis; Renner, Christophe; Ollivier, Denis

2011-12-01

This guide aims at providing project holders with guidance on factors which may influence social acceptability of methanization projects and with recommendations regarding communication and dialogue for a better project integration, with a technical support in order to guarantee project quality for a minimised environmental impact, and at convincing and reassuring local communities which plan to implement a methanization project, notably with respect to issues like odours, safety or landscape integration. The guide first outlines the importance of a serious and credible approach, and aims project holders at demonstrating an actual reasonable economic control of energy, environmental and social issues related to their project. The second part proposes technical solutions regarding the limitation of impact on air quality, preservation and restoration of soil quality and water resources, landscape integration, transport management and noise prevention. Feedbacks on experiences with different types of installations (agricultural, industrial, and so on) are also provided. A good practice charter is finally proposed

Advances in participatory occupational health aimed at good practices in small enterprises and the informal sector.

Science.gov (United States)

Kogi, Kazutaka

2006-01-01

Participatory programmes for occupational risk reduction are gaining importance particularly in small workplaces in both industrially developing and developed countries. To discuss the types of effective support, participatory steps commonly seen in our "work improvement-Asia" network are reviewed. The review covered training programmes for small enterprises, farmers, home workers and trade union members. Participatory steps commonly focusing on low-cost good practices locally achieved have led to concrete improvements in multiple technical areas including materials handling, workstation ergonomics, physical environment and work organization. These steps take advantage of positive features of small workplaces in two distinct ways. First, local key persons are ready to accept local good practices conveyed through personal, informal approaches. Second, workers and farmers are capable of understanding technical problems affecting routine work and taking flexible actions leading to solving them. This process is facilitated by the use of locally adjusted training tools such as local good examples, action checklists and group work methods. It is suggested that participatory occupational health programmes can work in small workplaces when they utilize low-cost good practices in a flexible manner. Networking of these positive experiences is essential.

Manufacturing of biodrugs: need for harmonization in regulatory standards.

Science.gov (United States)

Sahoo, Niharika; Choudhury, Koel; Manchikanti, Padmavati

2009-01-01

Biodrugs (biologics) are much more complex than chemically synthesized drugs because of their structural heterogeneity and interactions within a given biologic system. The manufacturing process in the biodrug industry varies with each type of molecule and is far more elaborate and stringent due to the use of living organisms and complex substrates. Product purity and altered structural characteristics leading to potential immunogenicity have often been of concern when establishing quality and safety in the use of biodrugs. Regulatory compliance in manufacturing and commercialization of biodrugs involves quality control, quality assurance, and batch documentation. Many factors such as host cell development, cell bank establishment, cell culture, protein production, purification, analysis, formulation, storage, and handling are critical for ensuring the purity, activity, and safety of the finished product. Good Manufacturing Practice (GMP) for biodrugs has been developed in certain regions such as the EU, US, and Japan. Due to differences in manufacturing methods and systems, product-specific GMP guidelines are evolving. In general, there are variations in GMP guidelines between countries, which lead to difficulty for the manufacturers in conforming to different standards, thus entailing delays in the commercialization of biodrugs. There is a need to develop a unified regulatory guideline for biodrug manufacturing across various countries, which would be helpful in the marketing of products and trade. This review deals with the comparative framework and analysis of GMP regulation of biodrugs.

Study on Effect of Functional Competency on Performance of Indian Manufacturing Sector

Directory of Open Access Journals (Sweden)

Rameshwar Dubey

2011-08-01

Full Text Available India is one of the fastest emerging global manufacturing hub with a large number of firms shifting their manufacturing base to the country due to cheap labor and good supplier(s base. Over the years, India has the largest number of companies, outside of Japan, that have been recognized for excellence in quality. As many as 21 companies have received the Deming Excellence awards; 153 companies have achieved Total Productive Maintenance (TPM Excellence Award for their total productivity management practices by the Japan Institute of Plant Maintenance (JIPM committee (Source: IBEF, 2010. Here in this research article author(s conducted an empirical survey among Indian manufacturing firms to understand how manufacturing competency effect the firm performance. It has been observed that manufacturing competency has negative impact on firm performance which is contradicting with the so far empirical studies conducted in European, Japanese and American countries. Here in this study authors provides in depth analysis to explain this negative impact and how this can lead to positive impact.

Application of a good manufacturing practices checklist and enumeration of total coliform in swine feed mills

Directory of Open Access Journals (Sweden)

Debora da Cruz Payao Pellegrini

2014-02-01

Full Text Available A cross-sectional study in four swine feed mills aimed to evaluate the correlation between the score of the inspection checklist defined in the Normative Instruction 4 (IN 4/ Brazilian Ministry of Agriculture, Livestock and Food Supply, and the enumeration of total coliforms throughout the manufacturing process. The most of non-conformities was found in the physical structure of the feed mills. Feed mill B showed the lowest number of unconformities while units A and D had the largest number of nonconformities. In 38.53% (489/1269 of the samples the presence of total coliform was detected, however no significant difference in the bacterial counts was observed between sampling sites and feed mills. The logistic regression pointed higher odds ratio (OR for total coliforms isolation at dosing (OR = 9.51, 95% CI: 4.43 to 20.41, grinding (OR = 7.10, 95% CI = 3.27 to 15.40 and residues (OR = 6.21, 95% CI: 3.88 to 9.95 In spite of having the second score in the checklist inspection, feed mill C presented the highest odds for total coliforms isolation (OR= 2,43, IC 95%: 1,68-3,53. The data indicate no association between the score of checklist and the presence of hygienic indicators in feed mills.

Manufacturing strategies for time based competitive advantages

OpenAIRE

Lin, Yong; Ma, Shihua; Zhou, Li

2012-01-01

Purpose – The main purpose of this paper is to investigate the current manufacturing strategies and practices of bus manufacturers in China, and to propose a framework of manufacturing strategies for time-based competitive advantages.\\ud Design/methodology/approach – The conceptual research framework is devised from a review of the literature, and case studies are used to investigate the manufacturing strategies and practices in place in the case companies. Data is collected through semi-stru...

WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants

National Research Council Canada - National Science Library

Simon, James E; Fong, Harry H.S; Regalado, Jacinto

2003-01-01

... Consultation on Good Agricultural and Field Collection Practices for Medicinal Plants, held in Geneva, Switzerland in July 2003 to review the draft guidelines (see Annex 6), and to the experts who participated in the WHO Working Group Meeting held in Geneva, Switzerland in October 2003, to review and revise the draft guidelines. Acknowledg...

Practical Strategies for Integrating Final Ecosystem Goods and Services into Community Decision-Making.

Science.gov (United States)

The concept of Final Ecosystem Goods and Services (FEGS) explicitly connects ecosystem services to the people that benefit from them. This report presents a number of practical strategies for incorporating FEGS, and more broadly ecosystem services, into the decision-making proces...

[Good professional practices of French CICs - version # 2].

Science.gov (United States)

Chevassus, Hugues; Duchesne, Charlène; Sailly, Annabelle; Vigouroux, Céline; Foulon, Christine; Kubiak, Christine; Binquet, Christine; Felin, Alexandra Lamotte; Chaud, Pascal; Thalamas, Claire; Cornu, Catherine

2017-10-01

French clinical investigation centers (CICs) are academic platforms dedicated to clinical research. The QUALI-CIC working group helps to improve and harmonize practices within the CIC network. After some years of implementation, the manual of good professional practices of CICs (MGPP CIC) completed in 2010, needed to be revised to best fit with the large panel of CIC activities. The aim was also to make it more accurate and to reinforce requirements about participants safety and data security. In its second version published in the present article, the MGPP CIC includes 255 items divided into 15 chapters. An explanatory document, currently being drafted, will complete the manual to facilitate its implementation. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Cost and Management Accounting Practices: A Survey of Manufacturing Companies

Directory of Open Access Journals (Sweden)

Ali UYAR

2010-11-01

Full Text Available The purpose of this study is to explore cost and management accounting practices utilized by manufacturing companies operating in Istanbul, Turkey. The sample of the study consists of 61 companies, containing both small and medium-sized enterprises, and large companies. The data collection methodology of the study is questionnaire survey. The content of the questionnaire survey is based on several previous studies. The major findings of the study are as follows: the most widely used product costing method is job costing; the complexity in production poses as the highest ranking difficulty in product costing; the most widely used three overhead allocation bases are prime costs, units produced, and direct labor cost; pricing decisions is the most important area where costing information is used; overall mean of the ratio of overhead to total cost is 34.48 percent for all industries; and the most important three management accounting practices are budgeting, planning and control, and cost-volume-profit analysis. Furthermore, decreasing profitability, increasing costs and competition, and economic crises are the factors, which increase the perceived importance of cost accounting. The findings indicate that companies perceive traditional management accounting tools still important. However, new management accounting practices such as strategic planning, and transfer pricing are perceived less important than traditional ones. Therefore, companies need to improve themselves in this aspect.

Additive manufacturing for consumer-centric business models

DEFF Research Database (Denmark)

Bogers, Marcel; Hadar, Ronen; Bilberg, Arne

2016-01-01

Digital fabrication—including additive manufacturing (AM), rapid prototyping and 3D printing—has the potential to revolutionize the way in which products are produced and delivered to the customer. Therefore, it challenges companies to reinvent their business model—describing the logic of creating...... and capturing value. In this paper, we explore the implications that AM technologies have for manufacturing systems in the new business models that they enable. In particular, we consider how a consumer goods manufacturer can organize the operations of a more open business model when moving from a manufacturer......-centric to a consumer-centric value logic. A major shift includes a move from centralized to decentralized supply chains, where consumer goods manufacturers can implement a “hybrid” approach with a focus on localization and accessibility or develop a fully personalized model where the consumer effectively takes over...

Perceptions of Science Teachers on Implementation of Seven Principles for Good Practice in Education by Chickering and Gamson in Courses

Science.gov (United States)

Ugras, Mustafa; Asiltürk, Erol

2018-01-01

The present study aimed to determine the perceptions of science teachers on the implementation of the seven principles for good practice in education by Chickering and Gamson in their courses. Seven principles for good science education were used as a data collection tool in the survey. "The seven principles for good practice in science…

How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study

NARCIS (Netherlands)

Berger, M; Kooyman, P.J.; Makkee, M.; van der Zee, J.S.; Sterk, P. J.; van Dijk, J.; Kemper, E. M.

2016-01-01

Background: Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper

Manufacture of Damascus steel: Metallographic study

International Nuclear Information System (INIS)

Criado, A.J.; Martinez, J.A.; Calabres, R.; Arias, D.

1997-01-01

Damascus Steel is the denomination that the Europeans gave to the material with which the musulman swords were manufactured during the Era of the Crusades. This hypereutectoid steel presents a high content in carbon more than 0.8%, and in some cases up to 2% in weight. The secret of its good mechanical characteristics is based in the hot forging process in the temperatures interval between 650 and 850 degree centigree. The final quenching in water brine or other aqueous solutions, confers to the swords manufactured with this steel a good resistance to its cutting edge and a high toughness. In the present investigation, the manufacture processes of this type of steel are studied. Electronic scanning microscopy has been applied to the study of materials manufactured by the authors following the ancient craftsmen methods of forging and quenching. (Author) 16 refs

Best Manufacturing Practices: Report of Survey Conducted at Headquarters, U.S. Army Industrial Operations Command, ROck Island, IL

National Research Council Canada - National Science Library

Renner, Ernie

1997-01-01

This report was produced by the Best Manufacturing Practices (BMP) program, a unique industry and government cooperative technology transfer effort that improves the competitiveness of America's industrial base both here and abroad...

Surviving a Site Audit: Tips for Good Clinical Practice in an Implant Trial

NARCIS (Netherlands)

E.M.M. van Lieshout (Esther); S.M. Zielinski (Stephanie)

2009-01-01

textabstractAbstract The number of clinical trials involving implants for trauma and orthopedic surgery is increasing. The International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guideline has been developed in order to assure that the rights, safety, and well-being of trial

[Qualitative evaluation of employer requirements associated with occupational health and safety as good practice in small-scale enterprises].

Science.gov (United States)

Kuroki, Naomi; Miyashita, Nana; Hino, Yoshiyuki; Kayashima, Kotaro; Fujino, Yoshihisa; Takada, Mikio; Nagata, Tomohisa; Yamataki, Hajime; Sakuragi, Sonoko; Kan, Hirohiko; Morita, Tetsuya; Ito, Akiyoshi; Mori, Koji

2009-09-01

The purpose of this study was to identify what motivates employers to promote good occupational health and safety practices in small-scale enterprises. Previous studies have shown that small-scale enterprises generally pay insufficient attention to issues of occupational health and safety. These findings were mainly derived from questionnaire based surveys. Nevertheless, some small-scale enterprises in which employers exercise good leadership do take a progressive approach to occupational health and safety. Although good practices can be identified in small-scale enterprises, it remains unclear what motivates employers in small-scale enterprises to actively implement occupational health and safety practices. We speculated that identifying employer motivations in promoting occupational health would help to spread good practices among small-scale enterprises. Using a qualitative approach based on the KJ methods, we interviewed ten employers who actively promote occupational health and safety in the workplace. The employers were asked to discuss their views of occupational health and safety in their own words. A semi-structured interview format was used, and transcripts were made of the interviews. Each transcript was independently coded by two or more researchers. These transcripts and codes were integrated and then the research group members discussed the heading titles and structural relationships between them according to the KJ method. Qualitative analysis revealed that all the employers expressed a strong interest in a "good company" and "good management". They emphasized four elements of "good management", namely "securing human resources", "trust of business partners", "social responsibility" and "employer's health condition itself", and considered that addressing occupational health and safety was essential to the achievement of these four elements. Consistent with previous findings, the results showed that implementation of occupational health and safety

Deploying Serious Games for Management in Higher Education: lessons learned and good practices

Directory of Open Access Journals (Sweden)

Jannicke Baalsrud Hauge

2014-08-01

Full Text Available Deployment of serious games (SGs and their insertion in higher education (HE curricula is still low. The lacks papers describing deployment of SGs in HE critically showing educational benefits and providing guidelines and good practices for their use. With the present work, we intend to make a first step in this direction, by reporting our experience in using state of the art managerial SGs in MSc engineering/business courses in four different European universities. In order to describe and analyse the educational characteristics and effectiveness of each game, we propose to use two models that we have straightforwardly extracted from two major pedagogical paradigms: the Bloom’s revised cognitive learning goals taxonomy and the Kolb’s experiential learning cycle. Based on our experience, we also propose a set of lessons and good practices to incentivize and better support deployment of SGs in HE courses.

Business ethics: the materiel/manufacturing perspective.

Science.gov (United States)

Marucheck, A S; Robbins, L B

1990-08-01

The discussion of purchasing practices and product integrity, which have ethical implications for materiel/manufacturing management, serves to illustrate how routine decisions can have larger implications for the firm as a whole. Management needs to take a proactive role in confronting ethical issues by (1) demonstrating a corporate commitment to sound ethics in business practices, (2) providing written policies where appropriate to provide a basis for sound ethical conducts, (3) educating various functional areas to understand their responsibility in seeming unrelated ethical problems, (4) delegating authority in ethical issues where such issues are considered in decision making, and (5) fostering interfunctional communication as a means in establishing corporatewide responsibility. The basic philosophical principles of JIT serve as a blueprint for recognizing and managing ethical responsibility. The unexpected by-products of a JIT implementation may be vendor/customer good will and an excellent reputation for the firm.

Preoperative Site Marking: Are We Adhering to Good Surgical Practice?

Science.gov (United States)

Bathla, Sonia; Chadwick, Michael; Nevins, Edward J; Seward, Joanna

2017-06-29

Wrong-site surgery is a never event and a serious, preventable patient safety incident. Within the United Kingdom, national guidance has been issued to minimize the risk of such events. The mandate includes preoperative marking of all surgical patients. This study aimed to quantify regional variation in practice within general surgery and opinions of the surgeons, to help guide the formulation and implementation of a regional general surgery preoperative marking protocol. A SurveyMonkey questionnaire was designed and distributed to 120 surgeons within the Mersey region, United Kingdom. This included all surgical trainees in Mersey (47 registrars, 56 core trainees), 15 consultants, and 2 surgical care practitioners. This sought to ascertain their routine practice and how they would choose to mark for 12 index procedures in general surgery, if mandated to do so. A total of 72 responses (60%) were obtained to the SurveyMonkey questionnaire. Only 26 (36.1%) said that they routinely marked all of their patients preoperatively. The operating surgeon marked the patient in 69% of responses, with the remainder delegating this task. Markings were visible after draping in only 55.6% of marked cases. Based on our findings, surgeons may not be adhering to "Good Surgical Practice"; practice is widely variable and surgeons are largely opposed and resistant to marking patients unless laterality is involved. We suggest that all surgeons need to be actively engaged in the design of local marking protocols to gain support, change practice, and reduce errors.

The principles of the motivational organization of the manufacture and the distribution of the goods at macro-levels

Directory of Open Access Journals (Sweden)

Astaf'ev Igor' Vladimirovič

2012-01-01

Full Text Available The global economic crisis, which has overwhelmed almost all developed countries, is not only a social problem, a problem of the policy, or management, but also the indicator of the necessity of the transition to an essentially new, qualitatively more perfect way of the organization of manufacture and distribution of the goods at macro-level. The existing economic theory, until now, offers two single-level alternatives - the concept of liberal market fundamentalism (laissez faire, and as opposed to it - the planned state-system and different variations and convergent schemes on their bases. However, the main obstacle for the reception of the synergetic effect, according to the theory of systems, is the absence of the third element along with principally, other, over-economical properties, connecting the economy with the unfamiliar areas of moral, cultures and ethics. Such an element in the new concept of the organization of a social production and distribution of the goods, whose bases are given below, acts as the united hierarchical motivational system.

Good editorial practice: editors as educators.

Science.gov (United States)

Marusić, M; Marusić, A

2001-04-01

There may be valuable research going on in the developing and financially less-privileged countries, but it usually does not reach international visibility, in spite of a large number of scientific journals in these countries. Such journals are not only invisible but, by perpetuating a vicious circle of inadequacy, may be directly damaging to the local science and research culture. We call for an international action to help journal editors in less privileged countries. International associations of editors may be leaders of these activities by defining, promoting, and perhaps controlling good editorial practice, as a main criterion for international recognition of a journal. However, the editors of small journals have the power and moral obligation to become a stronghold of quality and advancement in their scientific community. Their educational "tools" are editorial integrity and author-friendly policy. Editors can teach the authors study design, statistical analysis, precision, punctuality, research integrity, style and format of writing, and other aspects of scientific communication. The editors of "big", mainstream scientific journals can act as global educators, teaching and providing guidance to editors of small journals. The editors from developed countries as leaders, and editors from less advantageous environments as teachers are the key figures in shaping research communication in less privileged scientific communities.

[Good practices and techniques for prevention of accidents at work and occupational diseases. New database of Inail].

Science.gov (United States)

Bindi, L; Ossicini, A

2007-01-01

The project "The publication of good practices and good techniques for prevention" is one the priorities of nail. This computerized system for the collection of good practices and standards of Good Technology is aimed to health and safety of workers. The basic objective of the database is to provide a valuable tool, usable, dynamic and implemented, in order to facilitate and direct the access to BP and BT it by people responsible for SSL. At the same time constitutes a tool strategically important for enterprises (especially SMEs) in terms of technological innovation and competitiveness, related to the prevention, safety and health of workers. The realization of this project has involved many of the professionals (chemists, engineers, doctors, biologists, geologists, etc.), and everyone gives his intake of qualified professional competence.

How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study

NARCIS (Netherlands)

Berger, M.; Kooyman, P. J.; Makkee, M.; van der Zee, J. S.; Sterk, P. J.; van Dijk, J.; Kemper, E. M.

2016-01-01

Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper performance of the

Configurable intelligent optimization algorithm design and practice in manufacturing

CERN Document Server

Tao, Fei; Laili, Yuanjun

2014-01-01

Presenting the concept and design and implementation of configurable intelligent optimization algorithms in manufacturing systems, this book provides a new configuration method to optimize manufacturing processes. It provides a comprehensive elaboration of basic intelligent optimization algorithms, and demonstrates how their improvement, hybridization and parallelization can be applied to manufacturing. Furthermore, various applications of these intelligent optimization algorithms are exemplified in detail, chapter by chapter. The intelligent optimization algorithm is not just a single algorit

Impacts of Good Practices on Cognitive Development, Learning Orientations, and Graduate Degree Plans during the First Year of College

Science.gov (United States)

Cruce, Ty M.; Wolniak, Gregory C.; Seifert, Tricia A.; Pascarella, Ernest T.

2006-01-01

This study estimated separately the unique effects of three dimensions of good practice and the global effects of a composite measure of good practices on the cognitive development, orientations to learning, and educational aspirations of students during their first year of college. Analyses of longitudinal data from a representative sample of…

The relationships between Lean manufacturing, management accounting and firm performance

DEFF Research Database (Denmark)

Kristensen, Thomas Borup; Nielsen, Henrik; Grasso, Lawrency

2016-01-01

with management accounting practices. Specifically, we document that Lean manufacturing is positively associated with Value Stream Costing, Lean visual controls and, more importantly, measures of labor and materials efficiency. Lean manufacturing is positively related to Lean thinking and both are positively...... associated with operational performance and so are Lean visual controls. We also document that the management accounting practices intervene affecting operational performance and they intervene with Lean thinking as well. Lastly, the relationship between Lean manufacturing and measures of labor and materials......Lean manufacturing has been adopted by numerous western companies as an answer to an increasing competitive environment. Lean manufacturing is seen as an enterprise-wide strategy encompassing a transformation of manufacturing practices, affecting companies’ management accounting practices and...

Deploying Serious Games for Management in Higher Education: lessons learned and good practices

NARCIS (Netherlands)

Baalsrud Hauge, Jannicke; Bellotti, Francesco; Nadolski, Rob; Kickmeier-Rust, Michael; Berta, Riccardo; Carvalho, Maria B.

2013-01-01

Baalsrud Hauge, J., Bellotti, F., Nadolski, R. J., Kickmeier-Rust, M., Berta, R., & Carvalho, M. B. (2013). Deploying Serious Games for Management in Higher Education: lessons learned and good practices. In C. Vaz de Carvalho, & P. Escudeiro (Eds.), Proceedings of the 7th European Conference on

Implications for climate change policy of trends in exports and imports of energy commodities and manufactured goods

International Nuclear Information System (INIS)

Ward, Murray

2005-11-01

A number of formal and informal policy processes are underway to explore the issue of 'where to next' for the international climate change regime post-2012. Currently these are informed by data based mainly on production statistics only. A key purpose of this study and report is to raise issues associated with trade in energy commodities and manufactured goods, in order to ensure that important perspectives which can be discerned from considering this 'consumption side' are not overlooked. A number of previous studies and papers have explored issues regarding embodied greenhouse gas emissions in traded energy commodities and manufactured goods. This study draws out key messages from these. It also expands on the existing literature by covering some non-CO2 greenhouse gas emissions, and also by considering traded renewables-based commodities. This work is not intended to be a comprehensive resource of quantitative data. Rather, examples of data are selected to help articulate and elaborate key issues. Section 2 describes the nature of the data sets that have been researched and utilised in developing any quantitative results. It outlines some relevant limitations of the methodologies underlying these data sets, and the nature of uncertainties. It also describes the methodology used in this work to unpack and/or re-present data. Section 3 provides data and analysis addressing the key objective noted above, i.e. to identify 'significant instances where transferred benefits and avoided costs occur - and the extent to which the exporter is likely to be compensated in the absence of policies intended for this purpose'. Section 4 draws out some of the key policy-relevant 'messages' and issues from this data. It uses a number of example cases to help do this, in a manner that is intended to be thought provoking, but not judgemental or prejudicial. Appendix A lists the existing literature that has informed this report. Appendix B reproduces a paper written on a subject that

Experience with quality assurance in fuel design and manufacturing

International Nuclear Information System (INIS)

Holzer, R.; Nilson, F.

1984-01-01

The Quality Assurance/Quality Control activities for nuclear fuel design and manufacturing described here are coordinated under a common ''Quality Assurance System For Fuel Assemblies and Associated Core Components'' which regulates the QA-functions of the development, design and manufacturing of fuel assemblies independent of the organizational assignment of the contributing technical groups. Some essential characteristics of the system are shown, using examples from design control, procurement, manufacturing and qualification of special processes. The experience is very good, it allowed a flexible and well controlled implementation of design and manufacturing innovations and contributed to the overall good fuel behavior. (orig.)

GOOD PRACTICES FOR SUSTAINABLE URBAN FOOD POLICIES

Directory of Open Access Journals (Sweden)

Cristina Elena NICOLESCU

2017-12-01

Full Text Available The paper, based on the coordinates of the problems triggered by the negative externalities chain generated by the poor food supply and production system at the level of the urban collectivities, carries out an analysis focused on the identification of the tools, mechanisms, and good practices needed to ensure the sustainability of the local policies on public nutrition. The experiences in the field show that the progress is remarkable in the case of collaborative administrations aimed at enhancing the cooperation and partnership relations, based on common interests, on both internal and international collaboration level, such as The Milan Urban Food Policy Pact (2015. From this perspective, the paper presents a case study, a significant experience of improving the food supply system of Bucharest population, through local public nutrition policy and the public action set implemented by Bucharest local authorities with the support of State public bodies and the representatives of civil society, materialized in the establishment of peasant markets as flea markets on the territory of Bucharest.

2008 report on the Monitoring of good practices programs and independence for electricity and natural gas system operators

International Nuclear Information System (INIS)

2009-01-01

Electricity and natural gas transmission system operators (TSO) and distribution system operators (DSO) are regulated operators that provide public service functions for the benefit of the network users and the consumers they serve. Accordingly, European and French law requires that they be under independent and nondiscriminatory obligations. In particular, they must develop a good practices program which includes a range of measures to prevent the risk of discriminatory practices in network access. Pursuant to Article L.134-15 of the Energy Code, the Energy Regulatory Commission (CRE) is publishing this year its 4. annual report on the monitoring of good practices programs and independence for electricity and natural gas system operators for the year 2008. This report is based on analysis of the 'reports on the implementation of good practices programs' submitted to the CRE by the operators in late 2008 and audits carried out by the CRE services in these companies in 2008

Defense programs beryllium good practice guide

Energy Technology Data Exchange (ETDEWEB)

Herr, M.

1997-07-01

Within the DOE, it has recently become apparent that some contractor employees who have worked (or are currently working) with and around beryllium have developed chronic beryllium disease (CBD), an occupational granulomatous lung disorder. Respiratory exposure to aerosolized beryllium, in susceptible individuals, causes an immunological reaction that can result in granulomatous scarring of the lung parenchyma, shortness of breath, cough, fatigue, weight loss, and, ultimately, respiratory failure. Beryllium disease was originally identified in the 1940s, largely in the fluorescent light industry. In 1950, the Atomic Energy Commission (AEC) introduced strict exposure standards that generally curtailed both the acute and chronic forms of the disease. Beginning in 1984, with the identification of a CBD case in a DOE contractor worker, there was increased scrutiny of both industrial hygiene practices and individuals in this workforce. To date, over 100 additional cases of beryllium-specific sensitization and/or CBD have been identified. Thus, a disease previously thought to be largely eliminated by the adoption of permissible exposure standards 45 years ago is still a health risk in certain workforces. This good practice guide forms the basis of an acceptable program for controlling workplace exposure to beryllium. It provides (1) Guidance for minimizing worker exposure to beryllium in Defense Programs facilities during all phases of beryllium-related work, including the decontamination and decommissioning (D&D) of facilities. (2) Recommended controls to be applied to the handling of metallic beryllium and beryllium alloys, beryllium oxide, and other beryllium compounds. (3) Recommendations for medical monitoring and surveillance of workers exposed (or potentially exposed) to beryllium, based on the best current understanding of beryllium disease and medical diagnostic tests available. (4) Site-specific safety procedures for all processes of beryllium that is likely to

Life‐cycle and cost of goods assessment of fed‐batch and perfusion‐based manufacturing processes for mAbs

Science.gov (United States)

Bunnak, Phumthep; Allmendinger, Richard; Ramasamy, Sri V.; Lettieri, Paola

2016-01-01

Life‐cycle assessment (LCA) is an environmental assessment tool that quantifies the environmental impact associated with a product or a process (e.g., water consumption, energy requirements, and solid waste generation). While LCA is a standard approach in many commercial industries, its application has not been exploited widely in the bioprocessing sector. To contribute toward the design of more cost‐efficient, robust and environmentally‐friendly manufacturing process for monoclonal antibodies (mAbs), a framework consisting of an LCA and economic analysis combined with a sensitivity analysis of manufacturing process parameters and a production scale‐up study is presented. The efficiency of the framework is demonstrated using a comparative study of the two most commonly used upstream configurations for mAb manufacture, namely fed‐batch (FB) and perfusion‐based processes. Results obtained by the framework are presented using a range of visualization tools, and indicate that a standard perfusion process (with a pooling duration of 4 days) has similar cost of goods than a FB process but a larger environmental footprint because it consumed 35% more water, demanded 17% more energy, and emitted 17% more CO2 than the FB process. Water consumption was the most important impact category, especially when scaling‐up the processes, as energy was required to produce process water and water‐for‐injection, while CO2 was emitted from energy generation. The sensitivity analysis revealed that the perfusion process can be made more environmentally‐friendly than the FB process if the pooling duration is extended to 8 days. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1324–1335, 2016 PMID:27390260

Encouraging Good Writing Practice in First-Year Psychology Students: An Intervention Using Turnitin

Science.gov (United States)

Betts, Lucy R.; Bostock, Stephen J.; Elder, Tracey J.; Trueman, Mark

2012-01-01

There is growing concern among many regarding plagiarism within student writing. This has promoted investigation into both the factors that predict plagiarism and potential methods of reducing plagiarism. Consequently, we developed and evaluated an intervention to enhance good practice within academic writing through the use of the plagiarism…

The importance of good time management in supporting succesful dental practice

OpenAIRE

Mita Juliawati

2016-01-01

n the globalization and Asean Economic Community (MEA) era, especially in the era of  competition and modern dentistry, dentists need increasing services in order to maintain and increase patient visits. Especially in patient’s complain about dental services that caused by unmanaged time, such as late dentist, long queue of patients and time inefficiency in dental practice. The objective of this review is to discuss the importance of good time management ’in supporting successful dental prati...

Safety practices in Jordanian manufacturing enterprises within industrial estates.

Science.gov (United States)

Khrais, Samir; Al-Araidah, Omar; Aweisi, Assaf Mohammad; Elias, Fadia; Al-Ayyoub, Enas

2013-01-01

This paper investigates occupational health and safety practices in manufacturing enterprises within Jordanian industrial estates. Response rates were 21.9%, 58.6% and 70.8% for small, medium and large sized enterprises, respectively. Survey results show that most companies comply with state regulations, provide necessary facilities to enhance safety and provide several measures to limit and control hazards. On the negative side, little attention is given to safety training that might be due to the lack of related regulations and follow-up, financial limitations or lack of awareness on the importance of safety training. In addition, results show that ergonomic hazards, noise and hazardous chemicals are largely present. Accident statistics show that medium enterprises have the highest accident cases per enterprise, and chemical industries reported highest total number of accidents per enterprise. The outcomes of this study establish a base for appropriate safety recommendations to enhance the awareness and commitment of companies to appropriate safety rules.

[How to promote the respect of good infusion practices by meeting health care professionals?].

Science.gov (United States)

Le Reste, C; Fiedler, A; Dubois, S; Dewailly, A; Le Du, I; Cogulet, V

2016-05-01

Health care professionals often forget that there are risks associated with infusion therapy even if it is a common care. In order to assess this practice and to draw potential improvement actions, an audit of local gravity-flow intravenous infusion practices was conducted. The audit, based on a grid including 66 items from the medical prescription to the end of the infusion therapy administration, was conducted in the 6 units which use the most gravity-flow intravenous infusion devices. A multidisciplinary working group was created to decide and organize priority corrective measures in order to improve infusion practices and quality of healthcare. The audit enabled to observe 90hours of nurse's practices (96 infusions) and highlighted heterogeneity in infusion, in some cases inappropriate infusion practices and misuse of infusion devices. We found 4 main issues: labelling infusion therapy, training of health care professionals on good practices, support the purchase of infusion pumps and standardize perfusion line. An interactive educational program for nurses (workshops) was organized to enhance the respect of good practices: infusion identification at any time, respect of hygiene rules, flow rate regulation by counting drops, appropriate use of pumps and flow rate regulators. The audit drew up work priorities. The workshops made easier exchanges between professionals and had a warm welcome that's why it is essential to carry on such training. This collaborative approach between pharmacists, nurses, hygienists and biomedical technicians contribute to drug management improvement and promote optimal patient care. Copyright © 2015 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

What Is "Good" Mentoring? Understanding Mentoring Practices of Teacher Induction through Case Studies of Finland and Australia

Science.gov (United States)

Pennanen, Matti; Bristol, Laurette; Wilkinson, Jane; Heikkinen, Hannu L. T.

2016-01-01

Mentoring is a practice widely utilised to support new teachers. However, in locally formed systems, the practice of mentoring is conditioned by traditions and arrangements specific to the site. To understand "good" mentoring, these local arrangements cannot be ignored. In this article, the theory of practice architectures is employed to…

Smart Manufacturing.

Science.gov (United States)

Davis, Jim; Edgar, Thomas; Graybill, Robert; Korambath, Prakashan; Schott, Brian; Swink, Denise; Wang, Jianwu; Wetzel, Jim

2015-01-01

Historic manufacturing enterprises based on vertically optimized companies, practices, market share, and competitiveness are giving way to enterprises that are responsive across an entire value chain to demand dynamic markets and customized product value adds; increased expectations for environmental sustainability, reduced energy usage, and zero incidents; and faster technology and product adoption. Agile innovation and manufacturing combined with radically increased productivity become engines for competitiveness and reinvestment, not simply for decreased cost. A focus on agility, productivity, energy, and environmental sustainability produces opportunities that are far beyond reducing market volatility. Agility directly impacts innovation, time-to-market, and faster, broader exploration of the trade space. These changes, the forces driving them, and new network-based information technologies offering unprecedented insights and analysis are motivating the advent of smart manufacturing and new information technology infrastructure for manufacturing.

29 CFR 779.108 - Goods produced for commerce.

Science.gov (United States)

2010-07-01

... 29 Labor 3 2010-07-01 2010-07-01 false Goods produced for commerce. 779.108 Section 779.108 Labor... Coverage Employees Engaged in Commerce Or in the Production of Goods for Commerce § 779.108 Goods produced for commerce. Goods are “produced for commerce” if they are “produced, manufactured, mined, handled or...

Performance-based risk-sharing arrangements-good practices for design, implementation, and evaluation: report of the ISPOR good practices for performance-based risk-sharing arrangements task force.

Science.gov (United States)

Garrison, Louis P; Towse, Adrian; Briggs, Andrew; de Pouvourville, Gerard; Grueger, Jens; Mohr, Penny E; Severens, J L Hans; Siviero, Paolo; Sleeper, Miguel

2013-01-01

There is a significant and growing interest among both payers and producers of medical products for agreements that involve a "pay-for-performance" or "risk-sharing" element. These payment schemes-called "performance-based risk-sharing arrangements" (PBRSAs)-involve a plan by which the performance of the product is tracked in a defined patient population over a specified period of time and the amount or level of reimbursement is based on the health and cost outcomes achieved. There has always been considerable uncertainty at product launch about the ultimate real-world clinical and economic performance of new products, but this appears to have increased in recent years. PBRSAs represent one mechanism for reducing this uncertainty through greater investment in evidence collection while a technology is used within a health care system. The objective of this Task Force report was to set out the standards that should be applied to "good practices"-both research and operational-in the use of a PBRSA, encompassing questions around the desirability, design, implementation, and evaluation of such an arrangement. This report provides practical recommendations for the development and application of state-of-the-art methods to be used when considering, using, or reviewing PBRSAs. Key findings and recommendations include the following. Additional evidence collection is costly, and there are numerous barriers to establishing viable and cost-effective PBRSAs: negotiation, monitoring, and evaluation costs can be substantial. For good research practice in PBRSAs, it is critical to match the appropriate study and research design to the uncertainties being addressed. Good governance processes are also essential. The information generated as part of PBRSAs has public good aspects, bringing ethical and professional obligations, which need to be considered from a policy perspective. The societal desirability of a particular PBRSA is fundamentally an issue as to whether the cost of

Social and Occupational Integration of Disadvantaged People. Leonardo da Vinci Good Practices Series.

Science.gov (United States)

Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

This document profiles nine European programs that exemplify good practice in social and occupational integration of disadvantaged people. The programs profiled are as follows: (1) Restaurant Venezia (a CD-ROM program to improve the reading and writing skills of young people in Luxembourg who have learning difficulties); (2) an integrated…

VET Retention in Remote Aboriginal and Torres Strait Islander Communities. Good Practice Guide

Science.gov (United States)

National Centre for Vocational Education Research (NCVER), 2017

2017-01-01

This good practice guide is based on the research project "Enhancing training advantage for remote Aboriginal and Torres Strait Islander learners" by John Guenther et al. on behalf of Ninti One Limited. The project examines five unique and successful vocational education and training (VET) programs in remote areas and identifies how…

Evaluation of the Implementation of Good Handling Practices in Food and Beverage Areas of Hotels.

Science.gov (United States)

Serafim, A L; Hecktheuer, L H R; Stangarlin-Fiori, L; Medeiros, L B; Martello, L; Machado, C E

2015-11-01

Because of the major international-level events that have recently been held in Brazil, concerns about the sensory and hygienic-sanitary conditions of food have increased. The objective of this study was to evaluate the implementation of good handling practices in food and beverage areas of hotels, with and without outsourced professional intervention. We evaluated 19 food and beverage areas in hotels in Porto Alegre, Rio do Sul, Brazil, using a checklist that was developed by a municipal surveillance team based on existing laws for good handling practices. The evaluation was done by a skilled professional in the food safety area on two occasions, at the beginning of the study (January to May 2013) and at the end (July to November 2014), and the establishments were classified as good, regular, or poor. After the baseline evaluation, an action plan listing the noncompliance found at each location was given to those responsible for the establishments, and a period of 1 year 6 months was stipulated for improvements to be made. In the repeat evaluation, those responsible for the establishments were asked whether they had hired an outsourced professional to assist them in the improvements. The hotels showed improvement during the repeat evaluation, but a significant increase in the percentage of overall adequacy was seen only in the food and beverages areas of the 12 hotels that used the intervention of an outsourced professional. The better percentage of adequacy in establishments with outsourced professional intervention underlines the importance of an external and impartial view of routine activities in the implementation of good handling practices.

Computer integrated manufacturing in the chemical industry : Theory & practice

NARCIS (Netherlands)

Ashayeri, J.; Teelen, A.; Selen, W.J.

1995-01-01

This paper addresses the possibilities of implementing Computer Integrated Manufacturing in the process industry, and the chemical industry in particular. After presenting some distinct differences of the process industry in relation to discrete manufacturing, a number of focal points are discussed.

The constraints of good governance practice in national solid waste management policy (NSWMP) implementation: A case study of Malaysia

Science.gov (United States)

Wee, Seow Ta; Abas, Muhamad Azahar; Chen, Goh Kai; Mohamed, Sulzakimin

2017-10-01

Nowadays, international donors have emphasised on the adoption of good governance practices in solid waste management which include policy implementation. In Malaysia, the National Solid Waste Management Policy (NSWMP) was introduced as the main guideline for its solid waste management and the Malaysian government has adopted good governance practice in the NSMWP implementation. However, the good governance practices implemented by the Malaysian government encountered several challenges. This study was conducted to explore the good governance constraints experienced by stakeholders in the NSWMP implementation. An exploratory research approach is applied in this study through in-depth interviews with several government agencies and concessionaires that involved in the NSWMP implementation in Malaysia. A total of six respondents took part in this study. The findings revealed three main good governance constraints in the NSWMP implementation, namely inadequate fund, poor staff's competency, and ambiguity of policy implementation system. Moreover, this study also disclosed that the main constraint influenced the other constraints. Hence, it is crucial to identify the main constraint in order to minimise its impact on the other constraints.

Study of flow stress and spall strength of additively manufactured Ti-6-4 alloy

Science.gov (United States)

Cohen, Amitay; Paris, Vitaly; Yosef-Hai, Arnon; Gudinetsky, Eli; Tiferet, Eitan

2017-06-01

The use of additive manufacturing (AM) by Electron Beam Melting (EBM) or Selective Laser Melting (SLM) has extensively grown in the past few years. A major goal in AM is to manufacture materials with mechanical properties at least as good as traditionally manufactured materials. In this work we present results of planar impact tests and Split Hopkinson Pressure Bar tests (SHPB) on Ti-6-4 manufactured by EBM and SLM processes. Results of planar impact tests on SLM samples display slightly higher spall strength compared to EBM while the stress at Hugoniot elastic limit (HEL) is practically the same. Stress strain curves based on SHPB measurements at two different strain rates present similar plastic flow stresses for SLM and EBM processed Ti-6-4 alloy, while the flow stress is about 20% higher than reported for commercial reference material. The strain to failure of both materials shows considerable strain rate sensitivity. The results of post-mortem analysis of spall fracture will also be presented.

Some tooling for manufacturing research reactor fuel plates

International Nuclear Information System (INIS)

Knight, R.W.

1999-01-01

This paper will discuss some of the tooling necessary to manufacture aluminum-based research reactor fuel plates. Most of this tooling is intended for use in a high-production facility. Some of the tools shown have manufactured more than 150,000 pieces. The only maintenance has been sharpening. With careful design, tools can be made to accommodate the manufacture of several different fuel elements, thus, reducing tooling costs and maintaining tools that the operators are trained to use. An important feature is to design the tools using materials with good lasting quality. Good tools can increase return on investment. (author)

Some Tooling for Manufacturing Research Reactor Fuel Plates

International Nuclear Information System (INIS)

Knight, R.W.

1999-01-01

This paper will discuss some of the tooling necessary to manufacture aluminum-based research reactor fuel plates. Most of this tooling is intended for use in a high-production facility. Some of the tools shown have manufactured more than 150,000 pieces. The only maintenance has been sharpening. With careful design, tools can be made to accommodate the manufacture of several different fuel elements, thus, reducing tooling costs and maintaining tools that the operators are trained to use. An important feature is to design the tools using materials with good lasting quality. Good tools can increase return on investment

Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

Directory of Open Access Journals (Sweden)

Tzu-Wei Li

2015-01-01

Full Text Available The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.

Applying a manufacturing vision development prototype in practice

DEFF Research Database (Denmark)

Wang, Chengbo; Luxhøj, James T.; Johansen, John

2005-01-01

The primary objective of this paper is to summarise the empirical application of a designed case-based manufacturing vision (MV) development prototype (CBRM). This empirical application is undertaken using case study strategy, due to its ability to answer the research questions regarding...... enterprise. The three real world cases (companies) were selected in the USA within different industrial segments. The application results suggest that the CBRM is supportive of the decision-making process for tackling strategic manufacturing issues....

Performance analysis of manufacturing systems : queueing approximations and algorithms

NARCIS (Netherlands)

Vuuren, van M.

2007-01-01

Performance Analysis of Manufacturing Systems Queueing Approximations and Algorithms This thesis is concerned with the performance analysis of manufacturing systems. Manufacturing is the application of tools and a processing medium to the transformation of raw materials into finished goods for sale.

Cloud Manufacturing Service Paradigm for Group Manufacturing Companies

Directory of Open Access Journals (Sweden)

Jingtao Zhou

2014-07-01

Full Text Available The continuous refinement of specialization requires that the group manufacturing company must be constantly focused on how to concentrate its core resources in special sphere to form its core competitive advantage. However, the resources in enterprise group are usually distributed in different subsidiary companies, which means they cannot be fully used, constraining the competition and development of the enterprise. Conducted as a response to a need for cloud manufacturing studies, systematic and detailed studies on cloud manufacturing schema for group companies are carried out in this paper. A new hybrid private clouds paradigm is proposed to meet the requirements of aggregation and centralized use of heterogeneous resources and business units distributed in different subsidiary companies. After the introduction of the cloud manufacturing paradigm for enterprise group and its architecture, this paper presents a derivation from the abstraction of paradigm and framework to the application of a practical evaluative working mechanism. In short, the paradigm establishes an effective working mechanism to translate collaborative business process composed by the activities into cloud manufacturing process composed by services so as to create a foundation resulting in mature traditional project monitoring and scheduling technologies being able to be used in cloud manufacturing project management.

Good Practice in Designing and Implementing National Monitoring Systems for Adaptation to Climate Change

DEFF Research Database (Denmark)

Naswa, Prakriti; Trærup, Sara Lærke Meltofte; Bouroncle, Claudia

In this report, we identify, analyse and compare international good practices in the design and implementation of national monitoring and evaluating indicator systems for climate change adaptation. This first chapter provides an introduction to the context and key terminology in the domain...

Vendor managed inventory (VMI practice analysis in a supplier of consumer goods

Directory of Open Access Journals (Sweden)

Denise Cervilha Freitas

2014-08-01

Full Text Available One of the widely discussed collaborative practices in the literature is Vendor Managed Inventory (VMI, which gives supplier the freedom to take decisions regarding customer´s replenishment, allowing better production planning. Despite the efforts of many researches, few studies compare the reality faced by companies with theories in the literature. Thus, this research aims to analyze the VMI practice of a consumer goods supplier with its retail customer, based on the barriers that limit the potential results of the practice and also the critical factors for the success of VMI. Insights from this analysis resulted in some propositions for future studies. The literature review allowed the identification of elements that influence the adoption and maintenance of VMI that were grouped into behavioral, cultural and physical elements. The method used was a case study with in-depth interviews, which allowed identifying the elements that limit the potential gains of VMI in the analyzed company and also those ones that contribute to the success of the practice.

Exposure monitoring of graphene nanoplatelets manufacturing workplaces.

Science.gov (United States)

Lee, Ji Hyun; Han, Jong Hun; Kim, Jae Hyun; Kim, Boowook; Bello, Dhimiter; Kim, Jin Kwon; Lee, Gun Ho; Sohn, Eun Kyung; Lee, Kyungmin; Ahn, Kangho; Faustman, Elaine M; Yu, Il Je

2016-01-01

at Workplace A. The TEM observation of the samples obtained from Workplaces A and B showed graphene-like structures and aggregated/agglomerated carbon structures. Taken together, the current findings on common scenarios (exfoliation, CVD growth, and transfer), while not inclusive of all graphene manufacturing processes, indicate very minimal graphene or particle exposure at facilities manufacturing graphenes with good manufacturing practices.

Guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals

International Nuclear Information System (INIS)

Dumas, Cecile

2010-07-01

Preparation of radiopharmaceuticals for injection involves adherence to regulations on radiation protection as well as to appropriate rules of working under aseptic conditions, which are covered by these guidelines on Good Radiopharmacy Practice (GRPP). The handling of radiopharmaceuticals is potentially hazardous. The level of risk depends in particular upon the types of radiation emitted and the half-lives of the radioactive isotopes. Particular attention must be paid to the prevention of cross-contamination, and to waste disposal. A continuous assessment of the effectiveness of the Quality Assurance system is essential to prove that the procedures applied in the Radiopharmacy Department lead to the expected quality. Clinical trials with new radiopharmaceuticals should follow these regulations on cGRPP as well as the Guideline on Good Clinical Practice. As there is a considerable difference in complexity in preparing 'classical' radiopharmaceuticals in 'kit' procedures and producing radiopharmaceuticals by distinct chemical procedures (Positron Emission Tomography (PET) Radiopharmaceuticals, in house prepared radiopharmaceuticals including in house prepared kits) these guidelines have been divided in two parts (A and B) respecting these differences

Numerical calculation and analysis of single-curvature polyhedron hydro-bulging process for manufacturing spherical vessels

International Nuclear Information System (INIS)

Dong Jianling; Zhang Fengke; Yin Dejian

2005-01-01

Single-curvature polyhedron hydro-bulging technology is a new technology for manufacturing spherical vessels and it has a good application foreground. This technology has been used in practice. But the designing and manufacturing of polyhedron is based on experiences, and the final quality of spherical vessels cannot be forecast quantitatively. In the paper, the FEM code, MARC, is used to simulate the hydrobulging process of a single-curvature polyhedron, including loading and offloading. And the distributions of stress and strain are acquired as well as other important data. Comparing with the experimental results, it shows that single-curvature polyhedron hydro-bulging process can be simulated well by the FEM code. (authors)

Organizing for manufacturing innovation. The case of Flexible Manufacturing Systems

DEFF Research Database (Denmark)

Boer, Harry; Krabbendam, Koos

1992-01-01

addressing the manufacturing innovation process are even fewer and provide little insight into its true nature. Consequently, little is known about the effective organization of such processes. In the present article an organization model of manufacturing innovation is described, and its practicability...... the implementation of new technology effectively. This is not surprising, considering the innovative nature of this process. Although there is a host of literature on innovation, organization and (the benefits of) new technology, the literature in which these areas are linked together is scarce. Publications...... assessed using the results of seven case studies of the implementation of flexible manufacturing systems in British, Belgian and Dutch mechanical engineering companies....

Characteristics of good quality pharmaceutical services common to community pharmacies and dispensing general practices.

Science.gov (United States)

Grey, Elisabeth; Harris, Michael; Rodham, Karen; Weiss, Marjorie C

2016-10-01

In the United Kingdom, pharmaceutical services can be delivered by both community pharmacies (CPs) and dispensing doctor practices (DPs). Both must adhere to minimum standards set out in NHS regulations; however, no common framework exists to guide quality improvement. Previous phases of this research had developed a set of characteristics indicative of good pharmaceutical service provision. To ask key stakeholders to confirm, and rank the importance of, a set of characteristics of good pharmaceutical service provision. A two-round Delphi-type survey was conducted in south-west England and was sent to participants representing three stakeholder groups: DPs, CPs and patients/lay members. Participants were asked to confirm, and rank, the importance of these characteristics as representing good quality pharmaceutical services. Thirty people were sent the first round survey; 22 participants completed both rounds. Median ratings for the 23 characteristics showed that all were seen to represent important aspects of pharmaceutical service provision. Participants' comments highlighted potential problems with the practicality of the characteristics. Characteristics relating to patient safety were deemed to be the most important and those relating to public health the least important. A set of 23 characteristics for providing good pharmaceutical services in CPs and DPs was developed and attained approval from a sample of stakeholders. With further testing and wider discussion, it is hoped that the characteristics will form the basis of a quality improvement tool for CPs and DPs. © 2016 Royal Pharmaceutical Society.

Use of technology in implementing radiation protection good practices at RAPS-5 and 6

International Nuclear Information System (INIS)

Nawal, S.R.; Kakkar, Amandeep; Yadav, Umed; Venkataramana, K.; Ramasomayajulu, M.; Khot, Pankaj

2014-01-01

Nuclear Power Corporation of India Ltd (NPCIL), is committed to perform all its activities while providing high level of radiological protection and continue to meet international standards on radiological safety. In continuation to reducing in expenditure of station collective dose/individual dose both in terms of external and internal dose is attained by adopting many new and innovative good radiological practices as per ALARA principle. Some of these improved radiological practices of RAPS-5 and 6 are discussed in this paper

SUPPLIER SELECTION STRATEGY AND MANUFACTURING FLEXIBILITY: IMPACT OF QUALITY AND TECHNOLOGY ROADMAPS

Directory of Open Access Journals (Sweden)

Muhamad Jantan

2006-01-01

Full Text Available The study evaluates the relationship between technology, quality, cost and delivery performance-based, supplier selection strategies, and manufacturing flexibilities namely, product flexibility, launch flexibility, and volume flexibility. Moreover, the moderating impact of supplier management strategies, namely quality roadmap and technology roadmap on the above relationships were also explored. The data for the study was drawn from a sample of companies listed in the factory directory published by the Penang Development Corporation (PDC. A postal survey of 120 manufacturers provided a return of 92 usable responses. The results reveal that the selection of suppliers based on technological and quality performance positively affects all the three dimensions of manufacturing flexibility, with complementary effects of good technology and quality roadmaps. Technology and quality roadmaps act as predictors for product and volume flexibilities. However, when launch flexibility is the focus, both technology and quality roadmaps moderate the impact of supplier selection strategies. Details of the findings, theoretical and practical implications, and the research limitation are discussed.

Annual report on the Monitoring of good practices programs and independence for electricity and natural gas system operators - 2006

International Nuclear Information System (INIS)

2007-01-01

Electricity and natural gas transmission system operators (TSO) and distribution system operators (DSO) are regulated operators that provide public service functions for the benefit of the network users and the consumers they serve. Accordingly, European and French law requires that they be under independent and nondiscriminatory obligations. In particular, they must develop a good practices program which includes a range of measures to prevent the risk of discriminatory practices in network access. Pursuant to Article L.134-15 of the Energy Code, the Energy Regulatory Commission (CRE) is publishing this year its 2. annual report on the monitoring of good practices programs and independence for electricity and natural gas system operators for the year 2006. This report is based on analysis of the 'reports on the implementation of good practices programs' submitted to the CRE by the operators in late 2006 and audits carried out by the CRE services in these companies in 2006

Annual report on the Monitoring of good practices programs and independence for electricity and natural gas system operators - 2007

International Nuclear Information System (INIS)

2008-01-01

Electricity and natural gas transmission system operators (TSO) and distribution system operators (DSO) are regulated operators that provide public service functions for the benefit of the network users and the consumers they serve. Accordingly, European and French law requires that they be under independent and nondiscriminatory obligations. In particular, they must develop a good practices program which includes a range of measures to prevent the risk of discriminatory practices in network access. Pursuant to Article L.134-15 of the Energy Code, the Energy Regulatory Commission (CRE) is publishing this year its 3. annual report on the monitoring of good practices programs and independence for electricity and natural gas system operators for the year 2007. This report is based on analysis of the 'reports on the implementation of good practices programs' submitted to the CRE by the operators in late 2007 and audits carried out by the CRE services in these companies in 2007

Good Practice Guide: Bringing a Social Capital Approach into the Teaching of Adult Literacy and Numeracy

Science.gov (United States)

National Centre for Vocational Education Research (NCVER), 2010

2010-01-01

This good practice guide is based on research that looked at how to teach adult literacy and numeracy using a social capital approach. The guide suggests ways vocational education and training (VET) practitioners can adopt a social capital approach to their teaching practice. A social capital approach refers to the process in which networks are…

Simulation of changes on the psychosocial risk in the nursing personnel after implementing the policy of good practices on the risk treatment.

Science.gov (United States)

Bolívar Murcia, María Paula; Cruz González, Joan Paola; Rodríguez Bello, Luz Angélica

2018-02-01

Evaluate the change over time of psychosocial risk management for the nursing personnel of an intermediate complexity clinic of Bogota (Colombia). Descriptive and correlational research performed under the approach of risk management (identification, analysis, assessment and treatment). The psychosocial risk of the nursing personnel was studied through 10-year system dynamics models (with and without the implementation of the policy of good practices on the risk treatment) in two scenarios: when the nursing personnel works shifts of 6 hours (morning or afternoon) and when they work over 12 hours (double shift or night shift). When implementing a policy of good practices on the risk treatment, the double shift scenario shows an improvement among 25% to 88% in the variables of: health, labor motivation, burnout, service level and productivity; as well as in the variables of the organization associated to number of patients, nursing personnel and profit. Likewise, the single shift scenario with good practices improves in all the above-mentioned variables and generates stability on the variables of absenteeism and resignations. The best scenario is the single shift scenario with the application of good practices of risk treatment in comparison with the double shift scenario with good practices, which allows concluding that the good practices have a positive effect on the variables of nursing personnel and on those associated to the organization. Copyright© by the Universidad de Antioquia.

Good practices and health policy analysis in European sports stadia: results from the 'Healthy Stadia' project.

Science.gov (United States)

Drygas, Wojciech; Ruszkowska, Joanna; Philpott, Matthew; Björkström, Olav; Parker, Mike; Ireland, Robin; Roncarolo, Federico; Tenconi, Maria

2013-06-01

Sport plays an important role within society and sports stadia provide significant settings for public health strategies. In addition to being places of mass gathering, stadia are often located in less affluent areas and are traditionally attended by 'harder to reach' communities. Unfortunately sports stadia and the clubs they host are rarely perceived as places that promote healthy lifestyles. Fast food, alcohol and tobacco are commonly advertized, served and consumed during sports games giving the spectators and TV fans contradictory messages concerning healthy choices. As part of a wider programme of work part-funded by the European Union, a study was therefore designed to explore current 'good practice' relating to positive health interventions in sports stadia across a number of European countries. Using a specially designed questionnaire, information about health policies and good practices relating to food offerings in stadia, physical activity promotion among local communities, tobacco policy, positive mental health initiatives, environmental sustainability practices and social responsibility policies were collected in 10 European countries (England and Northern Ireland, Finland, Georgia, Greece, Ireland, Italy, Latvia, Poland, Spain and Sweden) involving 88 stadia. The audit results show that stadia health policies differ considerably between specific countries and sports. Based on the literature analysed, the examples of good practices collected through the study, and the subsequent instigation of a European Healthy Stadia Network, it shows that there is considerable potential for stadia to become health promoting settings.

Validation of good agricultural practices (GAP) on Minnesota vegetable farms.

Science.gov (United States)

Hamilton, Karin E; Umber, Jamie; Hultberg, Annalisa; Tong, Cindy; Schermann, Michele; Diez-Gonzalez, Francisco; Bender, Jeff B

2015-02-01

The United States Food and Drug Administration and the Department of Agriculture jointly published the "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables," which is used as a basis for Good Agricultural Practices (GAP) audits. To understand barriers to incorporation of GAP by Minnesota vegetable farmers, a mail survey completed in 2008 was validated with visits to a subset of the farms. This was done to determine the extent to which actual practices matched perceived practices. Two hundred forty-six producers completed the mail survey, and 27 participated in the on-farm survey. Over 75% of the on-farm survey respondents produced vegetables on 10 acres or less and had 10 or fewer employees. Of 14 questions, excellent agreement between on-farm interviews and mail survey responses was observed on two questions, four questions had poor or slight agreement, and eight questions had no agreement. Ninety-two percent of respondents by mail said "they took measures to keep animals and pests out of packing and storage buildings." However, with the on-site visit only 45% met this requirement. Similarly, 81% of respondents by mail said "measures were taken to reduce the risk of wild and/or domestic animals entering into fruit and vegetable growing areas." With direct observation, 70% of farms actually had taken measures to keep animals out of the growing areas. Additional, on-farm assessments were done regarding employee hygiene, training, presence of animals, water sources, and composting practices. This validation study demonstrated the challenge of creating nonleading and concise questions that are not open to broad interpretation from the respondents. If mail surveys are used to assess GAP, they should include open-ended questions and ranking systems to better assess farm practices. To provide the most accurate survey data for educational purposes or GAP audits, on-farm visits are recommended.

Good practices with respect to the development and use of nuclear power plant procedures

International Nuclear Information System (INIS)

1998-12-01

This technical publication is intended to provide information to nuclear power plant managers concerning good practices in respect to the development and use of NPP procedures. It is a part of an ongoing project on nuclear power plant instrumentation and control and is based on lessons learned from NPPs and utilities. The overall objective of this project is to provide systematic guidance on current and emerging instrumentation and control technologies including: protection and automation systems, control rooms, operator support systems, training simulators and human factors. It is intended to be applicable to NPPs in Member States that are in operation, under construction or being commissioned. The good practices described are consistent with the IAEA Safety Series recommendations with respect to the development and use of NPP procedures including the four categories: administrative procedures, operating procedures (normal, alarm response, abnormal and emergency procedures), maintenance and technical support procedures, and testing and surveillance procedures

GOOD PRACTICES REGARDING PRESCHOOL AND PRIMARY SCHOOL TEACHERS` INITIAL TRAINING

Directory of Open Access Journals (Sweden)

Gabriela V. KELEMEN

2013-11-01

Full Text Available The training of future preschool and primary school teachers at a high quality level is a main goal of our institution and all our efforts are channelled towards fulfilling it. Being a teacher is a science, a science based on competences acquired while attending well-structured lectures that mingle theoretical knowledge with practical assignments. Students acquire knowledge, abilities and develop field related competences during initial training but three years of study are not enough. The Law of Education regulates the following amendment: in order for a teacher to be well trained to meet the requirements of the third millennium it is necessary for him/her to continue the training in level II i.e. master degree, which provides additional competences. In this article we discuss a master programme developed within an European project that offers educational training according to the requirements of a high quality training both practical and theoretical. The components of the Master programme entitled Psychopedagogy of early education and young schooling containa curriculum adjusted to the requirements of a competitive higher education, the courses and seminars are the result of a thorough analysis of different educational models that have been implemented in other European countries. Currently, we are at the end of the first year and we want to share the good practices obtained so far.

GOOD PRACTICES IN THE FORMATION OF PROFESSIONAL EARLY CHILDHOOD EDUCATION

Directory of Open Access Journals (Sweden)

Elsy Fuentes-Garí

2016-07-01

Full Text Available The Project Network UNESCO Associated Schools (ASPnet is a project for the improvement of educational practices that implements a self-management model to achieve quality. The work presented socializes good practices used in the formation of professional children's education at the Central University "Marta Abreu" of Las Villas, with the inclusion of the objectives and priorities of ASPnet. It is a partial result of an educational research in order to achieve a general theoretical and methodological conception to insert the objectives and priorities of the network in the process of initial professional training. la-participatory action research is applied with the support of theoretical and empirical methods, including: document analysis, group interviews, observation, focus group and photographs, allowing the development of evaluative analysis and enrichment of existing theory. As significant results so far, it is evident that students expand their knowledge about transcendent global processes, take a positive position to contribute their action to sustainable development, to promote peace, to fight for human rights, respect to others and to promote intercultural learning. Show changes in their modes of action, in the university context and in their working practice, pass on their knowledge, promoting culture, environmental protection, energy savings, compliance with the law, sexuality, nutrition education, care of the physical and mental health, responsible behavior. Expressed further development of educational paraprofessionals to plan, implement and monitor strategies educational skills.

Open Manufacturing: Impacts of Resource Based View and Servitisation

DEFF Research Database (Denmark)

Yang, Cheng; Johansen, John

2010-01-01

The environment of manufacturing has faced significant changes in the past decade. Meanwhile, the traditional focus of manufacturing strategy is also impacted by resource-based view and servitisation. Thus, no matter from a practical or theoretical perspective, it is time to rethink what kind...... of view we can have on manufacturing. In this paper, the literature is reviewed firstly to track the evolution of theories on manufacturing strategy and to investigate new views on manufacturing from a theoretical perspective. This is followed by three case studies, which are used to explore how...... manufacturing is used from a practical perspective. The usages of manufacturing are classified into three groups and their relationships are discussed further. Based on these findings and inspired by open source software (OSS) and open innovation, a new paradigm on manufacturing termed as “open manufacturing...

Circular economy practices among Chinese manufacturers varying in environmental-oriented supply chain cooperation and the performance implications.

Science.gov (United States)

Zhu, Qinghua; Geng, Yong; Lai, Kee-hung

2010-06-01

The rapidly growing industrial activities in emerging economies such as China have been causing resource depletion and pollution problems. This reality requires China to adopt an integrated management approach to resolve the conflict between industrial development and environmental protection, and the concept of circular economy (CE) serves this purpose. In this paper, we examine if different types of manufacturing enterprises on environmental-oriented supply chain cooperation (ESCC) exist. We also determine if the Chinese manufacturer types varying in ESCC differ in their implementation of the CE practices towards achieving the CE-targeted goals on improving both environmental and economic performance. Our cluster analytic results with multivariate analysis of variance (MANOVA) among the four identified types of Chinese manufacturers varying in environmental-oriented supply chain cooperation highlight the importance to intensify the cooperation with upstream and downstream supply chain partners for a CE initiative to succeed. (c) 2010 Elsevier Ltd. All rights reserved.

Creating Value for Customer in Business Networks of High-Tech Goods Manufacturers

Directory of Open Access Journals (Sweden)

Joanna Wiechoczek

2016-01-01

Full Text Available The main paper goal is to recognize the category of value for customer with respect to high-tech products, and to propose a model of creation of this value in business networks established by manufacturers. The research methods include critical analysis of the literature, documentation method, as well as the case research method and observation method. The results of the research proved that the value offered to buyers is characterized by growing multidimensionality which results in increasing complexity of the creation process of this value by their manufacturers. Due to the fact that they do not have complex skills and resources to create the value independently, they form business networks. These networks include increasingly larger group of entities, in which the importance of individual cooperants is highly diversified.

'Serial review on clinical PET tracers'. Manufacturing and quality control of positron emitting radiopharmaceuticals produced by in-house cyclotron

International Nuclear Information System (INIS)

Saji, Hideo

2009-01-01

In order to establish PET diagnosis as a routine clinical tool, manufacture's compliance with regulations under the Good Manufacturing Practice (GMP) principle for PET radiopharmaceuticals is necessary. For this purpose, the Sub-committee on Medical Application of Positron Emitting Radionuclides, Medical Science and Pharmaceutical Committee of Japan Radioisotopes Association has proposed 'Standards for Compounds Labeled with Emitting Radionuclides Approved as Established Techniques for Medical Use'. This guideline includes the general notices, general rules for preparations, general tests for the quality control, quality of each PET agents, guideline for manufacturing environment and manufacturing process at manufacturing facilities of PET agents. Each facility should have a committee and establish an internal system to account for manufacturing compounds labeled with positron emitting radionuclides produced in the facility, and compile standards by referring to the 'Established Standard Techniques of Labeling Compounds with Emitting Radionuclides for use as Radiopharmaceuticals: approved by the Subcommittee on Medical Application of Cyclotron-Produced Radionuclides (revised in 2009)', in order to maintain the quality of radiopharmaceuticals. (author)

Development of good modelling practice for phsiologically based pharmacokinetic models for use in risk assessment: The first steps

Science.gov (United States)

The increasing use of tissue dosimetry estimated using pharmacokinetic models in chemical risk assessments in multiple countries necessitates the need to develop internationally recognized good modelling practices. These practices would facilitate sharing of models and model eva...

Lean management in a non-manufacturing organization

Directory of Open Access Journals (Sweden)

Mladen Žvorc

2013-12-01

Full Text Available This paper examines the possibilities of a lean approach to non-manufacturing functions, i.e. a market-oriented organization. This refers to purchasing, shipment, storage, sale and delivery of goods; marketing, etc. A lean approach to business operations is discussed and several lean business methods are developed on the basis of which lean management can be used not only in manufacturing, but also in non-manufacturing organizations.

Linking human capital and enterprise sustainability in Indonesian medium-sized food manufacturing enterprises: the role of informal knowledge sharing practice

Science.gov (United States)

Sunardi, O.

2017-12-01

Medium-sized food manufacturing enterprises in Indonesia are significant in a number of contexts, in terms of their part to the national production (GDP) and their establishment to the employment. In term of their role to national production, manufacturing sector contributes the highest GDP by 85%. In this sector, food manufacturing subsector contributes the highest GDP. Nevertheless, they faced the same common problems: quality of human capital and sustainability issues. Previous government supplementary programs have been established to expand the human capital capability amongst medium enterprises. Adequate amount of fund has been apportioned to develop human capital, though, the medium enterprises sustainability is still in question. This study proposes and examines the human capital role from informal knowledge sharing perspective. By conducting qualitative approach through interviews to four informants in Indonesian medium-sized food manufacturing enterprises, a set of hypotheses is derived from this study for future quantitative study. This study indicates that human capital traits (diverse education background, employee skills, and employee experience) could leverage the practice of informal knowledge sharing. Constructs such as mutual trust and reciprocal intention could play as mediating variables, and cultural interpretation perspective could act as moderating factor to informal knowledge sharing effectiveness. In final, informal knowledge sharing is indicated to play as moderating variable for human capital policy and practice to support enterprise sustainability.

Exploiting HRM in support of lean manufacturing

DEFF Research Database (Denmark)

Jørgensen, Frances; Matthiesen, Rikke

The purpose of this paper is to investigate the ways in HRM practices are-and could potentially be-exploited to support lean manufacturing in practice. First, a review of the pertinent literature regarding HRM, SHRM, and lean manufacturing is presented to provide an understanding of the mechanisms...... by which HRM practices could, theoretically, be used to support a lean implementation. Data presented in the paper are derived from 1) a longitudinal case study on lean implementation and 2) from managers currently involved with lean manufacturing in a second company. The relevant literature and the data...... depicting the potential role in supporting HRM/lean integrated practices. The analysis of the model with respect to the theoretical background emphasizes a number of areas in which HRM could be more fully exploited in order to more successfully support lean implementation, for example, by stressing HRM...

The yuan-dollar parity and its effects on Mexico's exports of manufacturing goods

Directory of Open Access Journals (Sweden)

Víctor Manuel Cuevas Ahumada

2014-06-01

Full Text Available This paper evaluates the impact of Chinese exchange rate policy on Mexican manufacturing exports in the US market. To that end, an amplified export function which combines demandand supply-side variables is estimated. The empirical evidence shows that, in the long run, a real depreciation of the yuan visà- vis the US dollar reduces Mexican manufacturing sales in the US. The econometric work also suggests that lowering unit labor costs, perhaps by means of a comprehensive and coherent training policy package, could serve the purpose of offsetting the negative effects of an undervalued Chinese currency.

Self-assessment of safety culture in nuclear installations. Highlights and good practices

International Nuclear Information System (INIS)

2002-11-01

This report summarizes the findings of two IAEA Technical Committee Meetings on Safety Culture Self-Assessment Highlights and Good Practices. The meetings took place on 3-5 June 1998 and 23-25 October 2000 in Vienna, and involved an international cross-section of representatives who participated both in plenary discussions and working groups. The purpose of the meetings was to discuss the practical implications of evolutionary changes in the development of safety culture, and to share international experience, particularly on the methods used for the assessment of safety culture and good practices for its enhancement in an organization. The working groups were allocated specific topics for discussion, which included the following: organizational factors influencing the implementation of actions to improve safety culture; how to measure, effectively, progress in implementing solutions to safety culture problems; the symptoms of a weakening safety culture; the suitability of different methods for assessing safety culture; the achievement of sustainable improvements in safety culture using the results of assessment; the potential threats to the continuation of a strong safety culture in an organization from the many challenges facing the nuclear industry. The working groups, when appropriate, considered issues from both the utility's and the regulator's perspectives. This report will be of interest to all organizations who wish to assess and achieve a strong and sustainable safety culture. This includes not only nuclear power plants, but also other sectors of the nuclear industry such as uranium mines and mills, nuclear fuel fabrication facilities, nuclear waste repositories, research reactors, accelerators, radiography facilities, etc. The report specifically supplements other IAEA publications on this subject

Guide to good practices for training and qualification of instructors. DOE handbook

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-03-01

Purpose of this guide is to provide contractor training organizations with information that can be used to verify the adquacy and/or modify existing instructor training programs, or to develop new training programs. It contains good practices for the training and qualification of technical instructors and instructional technologists at DOE reactor and non-reactor nuclear facilities. It addresses the content of initial and continuing instructor training programs, evaluation of instructor training programs, and maintenance of instructor training records.

From Goods to Solutions

DEFF Research Database (Denmark)

Chakkol, Mehmet; Johnson, Mark; Raja, Jawwad

2014-01-01

Purpose – This paper aims to adopt service-dominant logic (SDL) to empirically explore network configurations resulting from the provision of goods, goods and services, and solutions. Design/methodology/approach – This paper uses a single, in-depth, exploratory case study in a truck manufacturer......: dyadic, triadic and tetradic. The extent to which different network actors contribute to value co-creation varies across the offerings. Research limitations/implications – This paper is based on a single, in-depth case study developed in one industrial context. Whilst this represents an appropriate...

Singing in Primary Schools: Case Studies of Good Practice in Whole Class Vocal Tuition

Science.gov (United States)

Lamont, Alexandra; Daubney, Alison; Spruce, Gary

2012-01-01

Within the context of British initiatives in music education such as the Wider Opportunities programme in England and the recommendations of the Music Manifesto emphasising the importance of singing in primary schools, the current paper explores examples of good practice in whole-class vocal tuition. The research included seven different primary…

Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

Science.gov (United States)

Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D

2015-03-01

drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high-quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Self-assessed competency at working with a medical interpreter is not associated with knowledge of good practice.

Directory of Open Access Journals (Sweden)

Patricia Hudelson

Full Text Available BACKGROUND: Specific knowledge and skills are needed to work effectively with an interpreter, but most doctors have received limited training. Self-assessed competency may not accurately identify training needs. PURPOSES: The purpose of this study is to explore the association between self-assessed competency at working with an interpreter and the ability to identify elements of good practice, using a written vignette. METHODS: A mailed questionnaire was sent to 619 doctors and medical students in Geneva, Switzerland. RESULTS: 58.6% of respondents considered themselves to be highly competent at working with a professional interpreter, but 22% failed to mention even one element of good practice in response to the vignette, and only 39% could name more than one. There was no association between self-rated competency and number of elements mentioned. CONCLUSIONS: Training efforts should challenge the assumption that working with an interpreter is intuitive. Evaluation of clinicians' ability to work with an interpreter should not be limited to self-ratings. In the context of large-scale surveys, written vignettes may provide a simple method for identifying knowledge of good practice and topics requiring further training.

Fundamentals of semiconductor manufacturing and process control

CERN Document Server

May, Gary S

2006-01-01

A practical guide to semiconductor manufacturing from process control to yield modeling and experimental design Fundamentals of Semiconductor Manufacturing and Process Control covers all issues involved in manufacturing microelectronic devices and circuits, including fabrication sequences, process control, experimental design, process modeling, yield modeling, and CIM/CAM systems. Readers are introduced to both the theory and practice of all basic manufacturing concepts. Following an overview of manufacturing and technology, the text explores process monitoring methods, including those that focus on product wafers and those that focus on the equipment used to produce wafers. Next, the text sets forth some fundamentals of statistics and yield modeling, which set the foundation for a detailed discussion of how statistical process control is used to analyze quality and improve yields. The discussion of statistical experimental design offers readers a powerful approach for systematically varying controllable p...

Manufacturing Enterprise in Asia

International Development Research Centre (IDRC) Digital Library (Canada)

2017-12-13

Dec 13, 2017 ... 53 Designing Financial Systems in East Asia and Japan ..... 5.3 Weights for the industrial production index (%) ..... The demand for manufactured goods for this low level of consumption per capita also tends to be very low.

GreyGuide - Guide to Good Practice in Grey Literature: A Community Driven Open Resource Project

OpenAIRE

Biagioni, Stefania (ISTI-CNR); Carlesi, Carlo (ISTI-CNR); Schopfel, Joachim (University of Lille); Farace, Dominic J. (GreyNet); Frantzen, Jerry (GreyNet); GreyNet, Grey Literature Network Service

2014-01-01

The goal of this project is to develop an open source repository of good practices in the field of grey literature. That which originated in monographic form will now open and expand to include content from the global grey literature community. Such practices will range from the production and processing of grey literature through to its distribution, uses, and preservation. The repository will contain guidelines such as those in handling theses and dissertations, how to write research report...

Fully Disposable Manufacturing Concepts for Clinical and Commercial Manufacturing and Ballroom Concepts.

Science.gov (United States)

Boedeker, Berthold; Goldstein, Adam; Mahajan, Ekta

2017-11-04

The availability and use of pre-sterilized disposables has greatly changed the methods used in biopharmaceuticals development and production, particularly from mammalian cell culture. Nowadays, almost all process steps from cell expansion, fermentation, cell removal, and purification to formulation and storage of drug substances can be carried out in disposables, although there are still limitations with single-use technologies, particularly in the areas of pretesting and quality control of disposables, bag and connections standardization and qualification, extractables and leachables (E/L) validation, and dependency on individual vendors. The current status of single-use technologies is summarized for all process unit operations using a standard mAb process as an example. In addition, current pros and cons of using disposables are addressed in a comparative way, including quality control and E/L validation.The continuing progress in developing single-use technologies has an important impact on manufacturing facilities, resulting in much faster, less expensive and simpler plant design, start-up, and operation, because cell culture process steps are no longer performed in hard-piped unit operations. This leads to simpler operations in a lab-like environment. Overall it enriches the current landscape of available facilities from standard hard-piped to hard-piped/disposables hybrid to completely single-use-based production plants using the current segregation and containment concept. At the top, disposables in combination with completely and functionally closed systems facilitate a new, revolutionary design of ballroom facilities without or with much less segregation, which enables us to perform good manufacturing practice manufacturing of different products simultaneously in unclassified but controlled areas.Finally, single-use processing in lab-like shell facilities is a big enabler of transferring and establishing production in emergent countries, and this is

The Evolution of the Theory and Practice of State Regulation of Addictive Goods Markets

Directory of Open Access Journals (Sweden)

Roman Yuryevich Skokov

2016-03-01

Full Text Available The article discusses the evolution of state regulation of the market of addictive goods and services in the context of the periodization of ideas about the role of the state in the economy in general, in historical and economic era, in the formation of the species of addictive goods markets. In the age of mercantilism the sphere of regulation of addictive goods markets was not the subject of attention of economists, but in practice there is an idea of the need for state protectionism. During its criticism in the framework of the theory of physiocrats and in the beginning of the classical school, alcohol products become a subject of research of economists, as the major source of budgetary funds. The abolition of serfdom, the development of private industrial activity, changing the farming tax system to the excise tax, indicate the penetration of traditional liberal principles in domestic economy in the field of addictive goods. The German historical schools focused on the active role of the state with respect to national peculiarities of the economy, found support and development in the works of Russian scientists that support the alcohol and tobacco monopoly. In the Soviet period the principles of Marxist political economy were formed on the basis of total nationalization of production and distribution of allowed addictive goods. The margin school is characterized by psychological interpretation of economic processes in the field of addictive goods under the conditions of perfect competition, in particular the role of consumers in the pricing. In the period of theoretical struggle of monetarism against keynesianism, which coincided with the drug boom, there were areas of economics of crime and punishment, drugs. In the neoliberalism period the antiprohibitionist movement was formed in the field of addictive goods. Changing some postulates of neoclassical economics by neo-institutional economic theory contributed to the development of empirical

Conjoint analysis applications in health--a checklist: a report of the ISPOR Good Research Practices for Conjoint Analysis Task Force.

Science.gov (United States)

Bridges, John F P; Hauber, A Brett; Marshall, Deborah; Lloyd, Andrew; Prosser, Lisa A; Regier, Dean A; Johnson, F Reed; Mauskopf, Josephine

2011-06-01

The application of conjoint analysis (including discrete-choice experiments and other multiattribute stated-preference methods) in health has increased rapidly over the past decade. A wider acceptance of these methods is limited by an absence of consensus-based methodological standards. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Research Practices for Conjoint Analysis Task Force was established to identify good research practices for conjoint-analysis applications in health. The task force met regularly to identify the important steps in a conjoint analysis, to discuss good research practices for conjoint analysis, and to develop and refine the key criteria for identifying good research practices. ISPOR members contributed to this process through an extensive consultation process. A final consensus meeting was held to revise the article using these comments, and those of a number of international reviewers. Task force findings are presented as a 10-item checklist covering: 1) research question; 2) attributes and levels; 3) construction of tasks; 4) experimental design; 5) preference elicitation; 6) instrument design; 7) data-collection plan; 8) statistical analyses; 9) results and conclusions; and 10) study presentation. A primary question relating to each of the 10 items is posed, and three sub-questions examine finer issues within items. Although the checklist should not be interpreted as endorsing any specific methodological approach to conjoint analysis, it can facilitate future training activities and discussions of good research practices for the application of conjoint-analysis methods in health care studies. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

The impact of manufacturing complexity drivers on performance-a preliminary study

Science.gov (United States)

Huah Leang, Suh; Mahmood, Wan Hasrulnizzam Wan; Rahman, Muhamad Arfauz A.

2018-03-01

Manufacturing systems, in pursuit of cost, time and flexibility optimisation are becoming more and more complex, exhibiting a dynamic and nonlinear behaviour. Unpredictability is a distinct characteristic of such behaviour and effects production planning significantly. Therefore, this study was undertaken to investigate the priority level and current achievement of manufacturing performance in Malaysia’s manufacturing industry and the complexity drivers on manufacturing productivity performance. The results showed that Malaysia’s manufacturing industry prioritised product quality and they managed to achieve a good on time delivery performance. However, for other manufacturing performance, there was a difference where the current achievement of manufacturing performances in Malaysia’s manufacturing industry is slightly lower than the priority given to them. The strong correlation of significant value for priority status was observed between efficient production levelling (finished goods) and finish product management while the strong correlation of significant value for current achievement was minimised the number of workstation and factory transportation system. This indicates that complexity drivers have an impact towards manufacturing performance. Consequently, it is necessary to identify complexity drivers to achieve well manufacturing performance.

Evaluating Students' Perspectives about Virtual Classrooms with Regard to Seven Principles of Good Practice

Science.gov (United States)

Çakýroðlu, Ünal

2014-01-01

This study assesses the quality of distance learning (DL) in higher education assessed by considering the Seven Principles of Good Practice (SPGP). The participants were 77 second-year students from the Computer and Instructional Technologies Program (CEIT) of a Faculty of Education in Turkey. A questionnaire was developed in line with the SPGP…

19 CFR 134.35 - Articles substantially changed by manufacture.

Science.gov (United States)

2010-04-01

... 19 Customs Duties 1 2010-04-01 2010-04-01 false Articles substantially changed by manufacture. 134... substantially changed by manufacture. (a) Articles other than goods of a NAFTA country. An article used in the United States in manufacture which results in an article having a name, character, or use differing from...

Decentralized manufacturing of cell and gene therapies: Overcoming challenges and identifying opportunities.

Science.gov (United States)

Harrison, Richard P; Ruck, Steven; Medcalf, Nicholas; Rafiq, Qasim A

2017-10-01

Decentralized or "redistributed" manufacturing has the potential to revolutionize the manufacturing approach for cell and gene therapies (CGTs), moving away from the "Fordist" paradigm, delivering health care locally, customized to the end user and, by its very nature, overcoming many of the challenges associated with manufacturing and distribution of high volume goods. In departing from the traditional centralized model of manufacturing, decentralized manufacturing divides production across sites or geographic regions. This paradigm shift imposes significant structural and organisational changes on a business presenting both hidden challenges that must be addressed and opportunities to be embraced. By profoundly adapting business practices, significant advantages can be realized through a democratized value chain, creation of professional-level jobs without geographic restriction to the central hub and a flexibility in response to external pressures and demands. To realize these potential opportunities, however, advances in manufacturing technology and support systems are required, as well as significant changes in the way CGTs are regulated to facilitate multi-site manufacturing. Decentralized manufacturing is likely to be the manufacturing platform of choice for advanced health care therapies-in particular, those with a high degree of personalization. The future success of these promising products will be enhanced by adopting sound business strategies early in development. To realize the benefits that decentralized manufacturing of CGTs has to offer, it is important to examine both the risks and the substantial opportunities present. In this research, we examine both the challenges and the opportunities this shift in business strategy represents in an effort to maximize the success of adoption. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

Science.gov (United States)

2012-08-16

... investigator initiated research. Topics for discussion include the following: (1) What FDA Expects in a...] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The...

Exposure to rubber fume and rubber process dust in the general rubber goods, tyre manufacturing and retread industries.

Science.gov (United States)

Dost, A A; Redman, D; Cox, G

2000-08-01

This study assesses the current patterns and levels of exposure to rubber fume and rubber process dust in the British rubber industry and compares and contrasts the data obtained from the general rubber goods (GRG), retread tire (RT) and new tire (NT) sectors. A total of 179 rubber companies were visited and data were obtained from 52 general rubber goods, 29 retread tire and 7 new tire manufacturers. The survey was conducted using a questionnaire and included a walk-through inspection of the workplace to assess the extent of use of control measures and the nature of work practices being employed. The most recent (predominantly 1995-97) exposure monitoring data for rubber fume and rubber process dust were obtained from these companies; no additional sampling was conducted for the purpose of this study. In addition to the assessment of exposure data, evaluation of occupational hygiene reports for the quality of information and advice was also carried out.A comparison of the median exposures for processes showed that the order of exposure to rubber fume (E, in mg m(-3)) is: E(moulding) (0.40) approximately E(extrusion) (0.33)>E(milling) (0.18) for GRG; E(press) (0. 32)>E(extrusion) (0.19)>E(autoclave) (0.10) for RT; and E(press) (0. 22) approximately E(all other) (0.22) for NT. The order of exposure to rubber fume between sectors was E(GRG) (0.40)>E(RT) (0.32)>E(NT) (0.22). Median exposures to rubber process dust in the GRG was E(weighing) (4.2)>E(mixing) (1.2) approximately E(milling) (0.8) approximately E(extrusion) (0.8) and no significant difference (P=0. 31) between GRG and NT sectors. The findings compare well with the study carried out in the Netherlands [Kromhout et al. (1994), Annals of Occupational Hygiene 38(1), 3-22], and it is suggested that the factors governing the significant differences noted between the three sectors relate principally to the production and task functions and also to the extent of controls employed. Evaluation of occupational

Guidebook on good practice in the management of uranium mining and mill operations and the preparation for their closure

International Nuclear Information System (INIS)

1998-12-01

Over the past fifty years the uranium industry has moved from a labor-intensive industry to a 'high-tech' and capital intensive industry. Organization of knowledge, manpower and material had to change to meet the demands of several stakeholders inherent to any project and to constantly adapt to technological innovations. Today, the mission of a uranium operation is not only to make a profit while selling yellow cake to electrical power stations but also to address issues regarding safety, health, environment and demands of the regulators and the public and assure the sustainability of the operations. Good mining practice begins with the proper planning and forecasting from the discovery of a deposit to decommissioning of a mine. This report describes and defines what is considered as good practice in the various activities of a mining operation and provides an overview of the management of a single operation. As technologies are progressing rapidly in the mining industry, and as this industry is transitional, this report emphasizes the importance of training employees at all levels of the organization. The statement on good practices for the various activities of a mining operation will be useful for organizations which are planning to open new mines or intend to modernize ongoing operations. Practical examples are given in the case of histories for four different countries. The objective of this publication is not to provide strict rules on the application of good practice but to give general guidelines that can be consulted and used in many different countries

16 CFR 700.2 - Date of manufacture.

Science.gov (United States)

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Date of manufacture. 700.2 Section 700.2... MAGNUSON-MOSS WARRANTY ACT INTERPRETATIONS OF MAGNUSON-MOSS WARRANTY ACT § 700.2 Date of manufacture... after July 4, 1975. When a consumer purchases repair of a consumer product the date of manufacture of...

Supplier Performance Monitoring and Improvement (SPMI through SIPOC Analysis and PDCA Model to the ISO 9001 QMS in Sports Goods Manufacturing Industry

Directory of Open Access Journals (Sweden)

2011-12-01

Full Text Available Background: Increasing global competition and customer expectations are forcing companies to improve their supplier performance as part of their supply chain governance initiative. A sport goods manufacturing industry is intensive supplier base industry and majority of these comes under small medium enterprises with limited resources. Developing an easy - deploy, cost effective and result oriented frame work for this industry is a critical business competency. Methods: This paper lays out a framework - a "standard operating system" - for continuous supplier performance monitoring and improvement (SPMI and is composed of following sections. In the first section supplier performance monitoring and improvement is overviewed with its basic concepts, and then improvement methods used in the paper are explained based on literature review. The third and fourth section focus on the methodology, explaining the way of SIPOC Analysis and PDCA application with using ISO 9001; 2008 QMS standards and example showing its results. Results: The existing process of Supplier Performance Monitoring and Improvement (SPMI was defined and mapped and then analyzed and revised through SIPOC Analysis by incorporating to PDCA Cycle and ISO 9001 QMS to identify problem areas, variations and unnecessary activities. Corrective actions were recommended to deal with problem areas and an improved and revised Supplier Performance Monitoring and Improvement (SPMI Process is suggested. Conclusions: Every organization needs to use a proper combination and selection of quality tools, methodologies and techniques for implementing continuous quality improvement process. This framework will provide a guidance for anyone who wants to develop supplier performance measurement system in sports goods manufacturing industry and other small - medium enterprises.

75 FR 78715 - Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging...

Science.gov (United States)

2010-12-16

... Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100... the SECG. FOR FURTHER INFORMATION CONTACT: Bradford Williams, Center for Food Safety and Applied... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0605...

Recent Regulatory Trends in Pharmaceutical Manufacturing and their Impact on the Industry.

Science.gov (United States)

Tabersky, Daniel; Woelfle, Michael; Ruess, Juan-Antonio; Brem, Simon; Brombacher, Stephan

2018-03-30

The pharmaceutical industry is one of the most regulated industries in Switzerland. Though the concept of good manufacturing practises (GMP) was implemented for chemical production in the early 1990s, the rules and regulations for our industry are in constant evolution. In this article we will highlight the impact of these changes to the industry using three recent guideline up-dates as examples: the implementation of ICH Q3D 'Guideline for elemental impurities', the EU-GMP Guideline Part III Chapter 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities' from 01. June 2015, and the new guidelines to data integrity such as 'PIC/S 041-1 Good Practices for Data Management and Integrity in regulated GMP/GDP environments'. These examples show how scientific approaches help to modernize the control strategies for our products and increase product quality for a better patient safety. The requirements of data integrity regulations are also of interest to industries and universities not working under GxP requirements as they also support the business to improve data quality (traceability) for patent applications, and reduce risk of data falsification.

Scalable microcarrier-based manufacturing of mesenchymal stem/stromal cells.

Science.gov (United States)

de Soure, António M; Fernandes-Platzgummer, Ana; da Silva, Cláudia L; Cabral, Joaquim M S

2016-10-20

Due to their unique features, mesenchymal stem/stromal cells (MSC) have been exploited in clinical settings as therapeutic candidates for the treatment of a variety of diseases. However, the success in obtaining clinically-relevant MSC numbers for cell-based therapies is dependent on efficient isolation and ex vivo expansion protocols, able to comply with good manufacturing practices (GMP). In this context, the 2-dimensional static culture systems typically used for the expansion of these cells present several limitations that may lead to reduced cell numbers and compromise cell functions. Furthermore, many studies in the literature report the expansion of MSC using fetal bovine serum (FBS)-supplemented medium, which has been critically rated by regulatory agencies. Alternative platforms for the scalable manufacturing of MSC have been developed, namely using microcarriers in bioreactors, with also a considerable number of studies now reporting the production of MSC using xenogeneic/serum-free medium formulations. In this review we provide a comprehensive overview on the scalable manufacturing of human mesenchymal stem/stromal cells, depicting the various steps involved in the process from cell isolation to ex vivo expansion, using different cell tissue sources and culture medium formulations and exploiting bioprocess engineering tools namely microcarrier technology and bioreactors. Copyright © 2016 Elsevier B.V. All rights reserved.

Good practices for user effect reduction - Status Report

International Nuclear Information System (INIS)

Ashley, R.; El-Shanawany, M.; Eltawila, F.; D'Auria, F.

1999-01-01

User effect has been identified in previous CSNI activities since 1991. The present report has as objectives to outline the consideration given to the user effect problem by various concerned organisations, and to present a consensus about recommended practices for user effect reduction. A survey of relevant literature is summarised, together with the answers collected through the Task Group on Thermal Hydraulics Applications members about characteristics of overall safety analysis process including validation, safety culture, staffing levels, staff competencies and responsibilities, on the job training, required documentation, and quality assurance. An outline is given of the adequacy demonstration process to be undertaken by a code user, when the code is being used in new situations for which assessment has not been performed by the code developers or by other user groups. A list of fifteen recommendations is set up, dealing with organisation and responsibilities, build up of competence, checks and assessments, and uncertainties. In summary: this report provides a review and discussion of earlier work relevant to the user effect on the results of system codes transient analyses; responses to a questionnaire proposed by the OECD/CSNI Task Group on Thermal-Hydraulic Applications are considered, together with results of activities started in 1991 in the same CSNI context. Some recommendations aim at reducing the user effect. These recommendations are generally based on good common practices adopted by organisations involved in safety analyses. Some of the reasons for the user effect are mentioned in the report. Code deficiencies may be to blame in a number of cases; however, here the attention is focussed on the application of the code and not on improving of the code models. A critical aspect is the internal organisation of institutions performing system code applications; the engagement of permanent and hired staff has a role in the quality and reliability of

Analysis of flow coefficient in chair manufacture

OpenAIRE

Ivković Dragoljub; Živković Slaven

2005-01-01

The delivery on time is not possible without the good-quality planning of deadlines, i.e. planning of the manufacturing process duration. The study of flow coefficient enables the realistic forecasting of the manufacturing process duration. This paper points to the significance of the study of flow coefficient on scientific basis so as to determine the terms of the end of the manufacture of chairs made of sawn timber. Chairs are the products of complex construction, often almost completely ma...

Optimizing production and imperfect preventive maintenance planning's integration in failure-prone manufacturing systems

International Nuclear Information System (INIS)

Aghezzaf, El-Houssaine; Khatab, Abdelhakim; Tam, Phuoc Le

2016-01-01

This paper investigates the issue of integrating production and maintenance planning in a failure-prone manufacturing system. It is assumed that the system's operating state is stochastically predictable, in terms of its operating age, and that it can accordingly be preventively maintained during preplanned periods. Preventive maintenance is assumed to be imperfect, that is when performed, it brings the manufacturing system to an operating state that lies between ‘as bad as old’ and ‘as good as new’. Only an overhauling of the system brings it to a ‘as good as new’ operating state again. A practical integrated production and preventive maintenance planning model, that takes into account the system's manufacturing capacity and its operational reliability state, is developed. The model is naturally formulated as a mixed-integer non-linear optimization problem, for which an extended mixed-integer linear reformulation is proposed. This reformulation, while it solves the proposed integrated planning problem to optimality, remains quite demanding in terms of computational time. A fix-and-optimize procedure, that takes advantage of some properties of the original model, is then proposed. The reformulation and the fix-and-optimize procedure are tested on some test instances adapted from those available in the literature. The results show that the proposed fix-and-optimize procedure performs quite well and opens new research direction for future improvements. - Highlights: • Integration of production planning and imperfect preventive maintenance is explored. • Imperfect maintenance is modeled using a fitting age reduction hybrid hazard rate. • A practical approximate optimization model for this integration is proposed. • The resulting naturally MINL optimization model is reformulated and solved as a MILP. • An effective fix-and-optimize procedure is proposed for large instances of this MILP.

Virtual manufacturing in reality

Science.gov (United States)

Papstel, Jyri; Saks, Alo

2000-10-01

SMEs play an important role in manufacturing industry. But from time to time there is a shortage in resources to complete the particular order in time. Number of systems is introduced to produce digital information in order to support product and process development activities. Main problem is lack of opportunity for direct data transition within design system modules when needed temporary extension of design capacity (virtuality) or to implement integrated concurrent product development principles. The planning experience in the field is weakly used as well. The concept of virtual manufacturing is a supporting idea to solve this problem. At the same time a number of practical problems should be solved like information conformity, data transfer, unified technological concepts acceptation etc. In the present paper the proposed ways to solve the practical problems of virtual manufacturing are described. General objective is to introduce the knowledge-based CAPP system as missing module for Virtual Manufacturing in the selected product domain. Surface-centered planning concept based on STEP- based modeling principles, and knowledge-based process planning methodology will be used to gain the objectives. As a result the planning module supplied by design data with direct access, and supporting advising environment is expected. Mould producing SME would be as test basis.

Performance Analysis of the Capability Assessment Tool for Sustainable Manufacturing

Directory of Open Access Journals (Sweden)

Enda Crossin

2013-08-01

Full Text Available This paper explores the performance of a novel capability assessment tool, developed to identify capability gaps and associated training and development requirements across the supply chain for environmentally-sustainable manufacturing. The tool was developed to assess 170 capabilities that have been clustered with respect to key areas of concern such as managing energy, water, material resources, carbon emissions and waste as well as environmental management practices for sustainability. Two independent expert teams used the tool to assess a sample group of five first and second tier sports apparel and footwear suppliers within the supply chain of a global sporting goods manufacturer in Asia. The paper addresses the reliability and robustness of the developed assessment method by formulating the expected links between the assessment results. The management practices of the participating suppliers were shown to be closely connected to their performance in managing their resources and emissions. The companies’ initiatives in implementing energy efficiency measures were found to be generally related to their performance in carbon emissions management. The suppliers were also asked to undertake a self-assessment by using a short questionnaire. The large gap between the comprehensive assessment and these in-house self-assessments revealed the suppliers’ misconceptions about their capabilities.

Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals

NARCIS (Netherlands)

Elsinga, Philip; Todde, Sergio; Penuelas, Ivan; Meyer, Geerd; Farstad, Brit; Faivre-Chauvet, Alain; Mikolajczak, Renata; Westera, Gerrit; Gmeiner-Stopar, Tanja; Decristoforo, Clemens

This guidance is meant as a guidance to Part B of the EANM "Guidelines on Good Radiopharmacy Practice (GRPP)" issued by the Radiopharmacy Committee of the EANM (see www.eanm.org), covering the small-scale "in house" preparation of radiopharmaceuticals which are not kit procedures. The aim is to

The Development of a Practical Framework for the Implementation of JIT Manufacturing

OpenAIRE

Hallihan, A.

1996-01-01

This research develops a framework to guide practitioners through the process of implementing Just In Time manufacturing in the commercial aircraft manufacturing industry. The scope of Just In Time manufacturing is determined through an analysis of its evolution and current use. Current approaches to its implementation are reviewed and shortcomings are identified. A requirement to allow practitioners to tailor the approach to the implementation of Just In Time manufacturing, ...

Using Additive Manufacturing to Reduce the Cost of Instrument Development

Data.gov (United States)

National Aeronautics and Space Administration — Additive Manufacturing (AM), commonly known as 3D printing, is widely used in the commercial sector for the manufacture of consumer goods, high performance parts for...

CT-assisted agile manufacturing