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Статті в журналах з теми "Good Manufacture Practice"
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NISHIJIMA, KAZUHIRO. "QA of blood product container ( manufacture ).Quality needed for blood bags and the practice of good manufacture practice (GMP)." Journal of the Japan Society of Blood Transfusion 41, no. 3 (1995): 247–50. http://dx.doi.org/10.3925/jjtc1958.41.247.
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Stout, K. J. "Engineering surfaces—a philosophy of manufacture (a proposal for good manufacturing practice)." Proceedings of the Institution of Mechanical Engineers, Part B: Journal of Engineering Manufacture 212, no. 3 (March 1, 1998): 169–74. http://dx.doi.org/10.1243/0954405981515581.
Повний текст джерелаАнотація:
This paper considers a new approach to controlling the finishing process of engineering surfaces to ensure that their final topography and surface mechanical properties make them suitable for the intended functional purpose. It is proposed that this ‘engineering’ of the final surface is achieved by controlling the final machining or surface working process to impart the required mechanical properties. It is shown in the paper that some surface engineering processes are already employed by industry but that many of these processes are implemented through an empirical understanding of them. The intention of the paper is to lay down a basis for a more rigorous approach to engineering surfaces for their final function.
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Burchett, D. H. "Food and drink manufacture: Good manufacturing practice — a guide to its responsible management." Food Control 1, no. 2 (April 1990): 125. http://dx.doi.org/10.1016/0956-7135(90)90098-w.
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Natalia, Hernández Jiménez, Ortuño Montero Natalia, Rojas Salas María Fernanda, Chavarría Rojas Marianela, Vargas Zúñiga Rolando, and Madrigal Redondo German Leonardo. "Analysis and Characterization of Quality Systems in the Natural Medicinal Products Industry in Costa Rica and the World." International Journal of Drug Regulatory Affairs 9, no. 4 (December 26, 2021): 6–19. http://dx.doi.org/10.22270/ijdra.v9i4.494.
Повний текст джерелаАнотація:
The use of natural products has been a practice carried out by people throughout history to take care of their health and to alleviate a wide variety of ailments. The reasons for the use of natural medicine at this time, with so many advances in pharmacology, are varied, among which are the dissatisfaction of the immediate needs of people to feel better about themselves and the economic factor. It must be considered that not everything natural is good. Therefore, the products manufactured and distributed under the line of Natural Medicinal Products must go through a verification and certification process, ensuring that they contain sufficient information on their composition and effects to avoid the risks that they may bring to those who consume them. This research describes good practices in the manufacture of natural products and shows the establishment of a Quality Management System in the pharmaceutical industry in different countries of the world. Finally, the use of natural products in Costa Rica is detailed, certain aspects to establish a Quality Management System in the country, as well as its importance.
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Lapteva, Natalia, and Juan F. Vera. "Optimization Manufacture of Virus- and Tumor-Specific T Cells." Stem Cells International 2011 (2011): 1–8. http://dx.doi.org/10.4061/2011/434392.
Повний текст джерелаАнотація:
Althoughex vivoexpanded T cells are currently widely used in pre-clinical and clinical trials, the complexity of manufacture remains a major impediment for broader application. In this review we discuss current protocols for theex vivoexpansion of virus- and tumor-specific T cells and describe our experience in manufacture optimization using a gas-permeable static culture flask (G-Rex). This innovative device has revolutionized the manufacture process by allowing us to increase cell yields while decreasing the frequency of cell manipulation andin vitroculture time. It is now being used in good manufacturing practice (GMP) facilities for clinical cell production in our institution as well as many others in the US and worldwide.
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Stoimenova, Assena H., Bogdan J. Kirilov, Stanislav R. Gueorguiev, Elina S. Petkova-Gueorguieva, and Sava G. Ognianov. "Good Manufacturing Practice for Medicinal Products in Bulgaria: an Analysis of Regulatory Inspection Findings." Folia Medica 62, no. 1 (March 31, 2020): 165–71. http://dx.doi.org/10.3897/folmed.62.e49802.
Повний текст джерелаАнотація:
Background: The manufacture of medicinal products for human use in the European Economic Area is governed by European Directives and Regulations stipulating the relevant principles and guidelines of Good Manufacturing Practice, describing the minimum standard to be fulfilled in the production processes. Aim: To present analysis of the deficiencies reported following Good Manufacturing Practice inspections in Bulgaria in two consecutive years (2016, 2017) and to compare them with results from similar inspections reported by other EU member states. Materials and methods: A retrospective study was carried out by reviewing the complete Good Manufacturing Practice inspection reports of all manufacturers conducted by the Bulgarian Drug Agency in 2016 and 2017, according to relevant requirements and applicable local legislation. The items reviewed were scope of inspection, type of companies, classification of deficiencies – ‘critical’, ‘major’ and ‘other significant deficiencies’, their nature and reference to EU Good Manufacturing Practice. Results: The analyzed data included 55 inspections, revealing 460 various deficiencies, of which 2 were critical and 102 – major. Twenty inspections were performed in 2016 vs. 35 inspections in 2017. The pattern of deficiencies was similar to the findings of other EU regulatory agencies, showing that equivalent requirements were applied. Our analysis showed that Bulgarian Drug Agency inspectors rarely raised deficiencies related to Computer Systems, Qualification/Validation, Personnel and Qualification of Suppliers unlike other EU regulators agents. Conclusions: Our analysis of Good Manufacturing Practice inspection findings in 2016 and 2017 showed that the Bulgarian Drug Agency demonstrated its ability to detect non-compliances and take necessary regulatory actions. Quality related issues constitute the main reasons for non-compliances with the requirements. Publishing the results from the inspections performed by the national competent authorities enhances the regulatory transparency that can be useful for industry to improve its Good Manufacturing Practice compliance.
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Zhu, Yao Wu, and Yue Xu. "Application of Computer Technology in the Simulation Process of Machine Design." Applied Mechanics and Materials 481 (December 2013): 217–19. http://dx.doi.org/10.4028/www.scientific.net/amm.481.217.
Повний текст джерелаАнотація:
Mechanical products are becoming increasingly precise after industrial revolutions. Design is important for the manufacture of those products. Good mechanical design can improve the quality of product, and the efficiency of manufacture. To find the problems in the design and then improve the design, it needed the simulation process after the mechanical design was completed. Computer technologies in simulation process, such as software technology and virtual technology, were deeply studied in this work which combined practice with the concept and characteristics of machine design.
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Huang, Jie, and Hong Jun Liu. "Research and Practice on the End Face Cylindrical Cam NC Machining Technology." Applied Mechanics and Materials 220-223 (November 2012): 406–9. http://dx.doi.org/10.4028/www.scientific.net/amm.220-223.406.
Повний текст джерелаАнотація:
This paper discussed the CAD / CAM technology of the end face cylindrical cam. The processing of end face cylindrical cam which used in textile machinery was analyzed, and the Processing plan was determined. Three-dimensional modeling and NC programming were done by respectively using PRO/E software and CAXA manufacture engineer software, machining accuracy, fixture and other key technical problems in the end face cylinder cam CAD/CAM process were solved. Acceptable product was processed in common three coordinates milling machine, and ultimately used in enterprises, and achieved good results.
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Rafael, Bence, Nóra Kuruczleki, and József Gál. "The way of the pharmaceutical ingredients to the finished pharmaceutical form." Analecta Technica Szegedinensia 12, no. 2 (December 5, 2018): 24–31. http://dx.doi.org/10.14232/analecta.2018.2.24-31.
Повний текст джерелаАнотація:
The modern pharmaceutical industry is a strictly controlled area. Both national and international rules apply, but none of these deals with logistical issues arising from the manufacture of the product. Following the path of a drug, it is possible to get acquainted with the problems that arise and their solution.
The drug is much more than a common product. The drug is a product of confidence, which is provided with information. It defines its quality as well, to comply with the relevant directives and standards in the manufacture of, and that the enclosed information is sent to the user.
This requires the manufacturer, the distributor and the user to comply with it. There is no production without material handling, but GMP (Good Manufacturing Practice) does not yet have a chapter on logistics. References to handling raw materials and finished products can be found in the corresponding GMP chapters, the responsibility of the correct execution are borne by the manufacturer. In this case, the effect of the common sense prevails exponentially, keep the medicine in mind and it has to be done, that no loss, no quality deterioration is not caused by the transport, handling of such loads, storage.
It is typical that the raw material and the finished product are going through the entire site during the pharmaceutical manufacture. Starting from the warehouse, it runs through the manufacturing facilities, on the packaging, and some units go to the lab, so that eventually, in medicine form returns to the warehouse, from where it goes further in the supply chain through the pharmacies to the patients.
In our study we examine the logistics activity and problems of a small pharmaceutical company and tasks to be solved presented in the light of the theory.
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Gándara, Carolina, Valerie Affleck, and Elizabeth Ann Stoll. "Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice." Human Gene Therapy Methods 29, no. 1 (February 2018): 1–15. http://dx.doi.org/10.1089/hgtb.2017.098.
Повний текст джерелаДисертації з теми "Good Manufacture Practice"
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Nabiça, Vanessa Cristina Olivença. "Desenvolvimento de um plano HACCP para uma unidade de produção de cerveja artesanal." Master's thesis, Universidade de Lisboa, Faculdade de Medicina Veterinária, 2019. http://hdl.handle.net/10400.5/18135.
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Dissertação de Mestrado em Segurança AlimentarTodos os operadores da agroindústria têm a obrigação de dar cumprimento ao Regulamento (CE) 852/2004 de 29 de abril de 2004. O fabrico artesanal de cerveja por ser uma atividade relativamente recente, apresenta algumas carências técnicas, o que gerou a necessidade de desenvolver um Manual de Boas Práticas de Higiene e Fabrico e um Plano HACCP, apresentado no presente trabalho. Pretende-se que sejam aplicados a estabelecimentos de fabrico artesanal de cerveja. Para tal foi acompanhada uma unidade artesanal de fabrico de cerveja com 2 colaboradores, localizada no distrito de Setúbal. Com o fácil acesso à informação, a crescente exposição e aceitação do produto no mercado português, torna-se vital que os produtores de cerveja artesanal implementem um sistema de garantia da segurança dos alimentos, por forma a garantir que o produto que colocam no mercado é seguro. Sendo por isso fundamental o auxílio desta documentação como tentativa de minimização de perigos. A produção de cerveja artesanal caracteriza-se por uma pequena quantidade produzida e pela ausência de duas etapas realizadas na produção industrial, a pasteurização e a filtração. É de realçar que os exemplos propostos foram elaborados para uma empresa em específico, servindo de modelo para outras realidades na área.
ABSTRACT - Development of a HACCP Plan for a craft beer manufacture unit - All agroindustry operators have to comply with the Regulation (EC) 852/2004 of 29 April 2004. The manufacture of craft beer is a recent activity and because of that it presents some technical faults, and it generated the necessity of developing a Code of Good Hygiene and Manufacturing Practices, which is proposed in this work. It is intended to be applied in manufacture of craft beer operations. To such purpose a unit of craft manufacture was followed with 2 collaborators, localized in the Setúbal district. With the easy access to information, growing exhibition and acceptance of the product in Portuguese marketplace, it becomes vital that handmade beer producers implement a food safety system. It ensures that the product they deliver in the marketplace is safe. This documentation is crucial to minimize the food safety dangerous. The manufacture of craft beer is characterized by being produced in small amounts and by the ausence of two phases, which are performed in industrial production, the pasteurization and filtration. It should be reinforced that the proposed examples were elaborated to a specific company, and it can be used as a template model to another realities.
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Silva, Lazaro Fleck. "PROCEDIMENTO OPERACIONAL PADRONIZADO DE HIGIENIZAÇÃO COMO REQUISITO PARA SEGURANÇA ALIMENTAR EM UNIDADE DE ALIMENTAÇÃO." Universidade Federal de Santa Maria, 2006. http://repositorio.ufsm.br/handle/1/5785.
Повний текст джерелаАнотація:
The World-wide Organization of health (OMS) indicates that amongst the disease of food origin, more than 60% of the cases elapse of inadequate techniques of processing, involving the pathogenic microorganisms and parasites, beyond its toxic products. When if it says in management of
quality in the industrialization and food manipulation, is obligatory the program of Good Manufacture Practices (GMP), and Hazard Analysis and Critical Control Point (HACCP). In foods unit the quality and safety is related to the productivity. For the aspect relative security to the consumer, these instruments provide to influence concepts of quality and safety that are fiscalized and implemented in
accordance with current law. For food unit is important that these also been engaged and sensitized of the importance to establish standards procedures hygienc, with sights to the sanitary hygienical conditions of the installations, equipment, utensils and manipulations hands. Provide to responsible
and manipulations base technique to on the safe food attainment the health of the consumers. Being thus the objective of this work it was to evaluate and to guarantee the microbiological safety and the quality of foods produced in food unit through of the adapt of relative operational procedures to the hygienic cleaning. To make possible this estudy, observed, and verified preliminary stages of hygienic
cleaning to the beginning of the work, after had been carried through awarenesses how much the methods, frequency and procedures of environment hygienic cleaning, equipment and utensils and hands. Realized verification and it collects of the samples of the equipment, utensils and hands used technique of "SWAB". The microbiological verifications seach been how much the mesophyllic aerobic microorganisms, mould and yeast, total coliform, termotolerants a 45°C coliform, positive
Estafilococos coagulase, Salmonella spp, Pseudomonas aeruginosa.The results of the carried through analyses demonstrate significant reduction, in the microbiological requirements above of 99,5 % after accomplishment of training and awareness and the adoption of the procedures and instructionsA Organização Mundial de Saúde (OMS) indica que dentre as doenças de origem alimentar, mais de 60% dos casos decorrem de técnicas inadequadas de processamento envolvendo os microrganismos e parasitas patogênicos, além de seus produtos tóxicos. Quando se fala em gestão de qualidade na industrialização e manipulação de alimentos, é obrigatório lembrar dos Procedimentos Operacionais Padronizados(POP s), Boas Práticas de Fabricação (BPF s) e Análise de Perigos e Pontos Críticos de Controle (APPCC/HACCP). Em unidades de alimentação a qualidade e segurança estão relacionadas à produtividade. Para o aspecto de segurança do consumidor, estas ferramentas proporcionam influenciar conceitos de qualidade e segurança alimentar que necessitam ser fiscalizados e implementados conforme exigência da legislação. Para unidades de alimentação é relevante que estas também estejam comprometidas e sensibilizadas da importância em estabelecer procedimentos operacionais padronizados de higiene, com vistas às condições higiênicas sanitárias de equipamentos, utensílios e mãos de manipuladores. Proporcionando base técnica aos responsáveis e manipuladores sobre a obtenção de alimentos seguros a saúde dos consumidores. O objetivo deste trabalho foi avaliar e garantir a segurança microbiológica e a qualidade de alimentos produzidos em unidade de alimentação através da adequação de procedimentos operacionais relativos à higienização. Para viabilizar esse estudo, foram observadas e verificadas etapas de higienização preliminares ao inicio do trabalho, após foram realizadas conscientizações quanto a métodos, freqüência e procedimentos de higienização de equipamentos, utensílios e mãos. Realizou-se verificação e coleta das amostras dos equipamentos, utensílios e mãos de manipuladores usando técnica de SWAB . As verificações microbiológicas pesquisadas foram quanto a microrganismos aeróbicos mesofilos, bolores e leveduras, coliformes totais, coliformes termotolerantes a 45°C, Estafilococos coagulase positiva, Salmonella spp e Pseudomonas aeruginosa. Os resultados das análises realizadas demonstram redução significativa, nos requisitos microbiológicos, acima de 99,5% após realização de treinamentos e conscientização e a adoção dos procedimentos e instruções
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Almeida, Elizabeth Nimrichter de. "Análise do trabalho de qualificação de fornecedores de insumos farmacêuticos da Unidade Farmanguinhos." reponame:Repositório Institucional da FIOCRUZ, 2009. https://www.arca.fiocruz.br/handle/icict/2515.
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Previous issue date: 2009Considerando a estreita relação entre a lógica econômica e as necessidades da área de saúde, o estudo em questão interliga o trabalho de Qualificação de Fornecedores de Insumos Farmacêuticos com o desempenho produtivo das Indústrias Farmacêuticas no contexto do Complexo Industrial da Saúde. Como objetivo evidencia o inter-relacionamento de ordem administrativa, técnica e operacional, frente o desempenho articulado entre os Procedimentos internos adotados por Farmanguinhos, seus processos de Aquisição, Validação, Manufatura e Inovação de Medicamentos, e a Qualidade e Especificidade dos Insumos Farmacêuticos adquiridos, demonstrando dentro desta ambiência, o impacto promovido pelo Trabalho de Qualificação de Fornecedores, em conformidade com os requisitos de qualidade visando às Boas Práticas de Fabricação. Como referencial teórico e regulatório, fundamenta além do contexto econômico, político e institucional capitalista associado à produção de bens e serviços do Complexo Industrial da Saúde, a representatividade da Indústria Farmacêutica frente à balança comercial nacional e desenvolvimento econômico, a conexão de conformidades entre os trabalhos de Validação e as Boas Práticas de Fabricação, bem como a interdependência entre a especificidade dos insumos farmacêuticos, seus processos de aquisição pelo setor público e os trabalhos de qualificação de fornecedores, tudo no âmbito da cadeia de produção de medicamentos. O impacto destes fundamentos frente à dinâmica administrativa, técnica e operacional produtiva de Farmanguinhos é evidenciado por informações oriundas de pesquisa exploratória, documental e de campo, empregada na metodologia de intervenção. Na análise de campo foram evidenciados procedimentos adotados por Farmanguinhos, relacionados com a aquisição pela administração pública e com a qualificação de fornecedores de insumos farmacêuticos, apresentando diagnóstico dos índices de reprovações das matérias-primas e medicamentos manufaturados e sua repercussão frente à demanda programada pelo Ministério da Saúde. Integrada à meta de excelência operacional de Farmanguinhos, a proposta identifica na Qualificação de Fornecedores, apoiada pelos trabalhos de Validação e Aquisições, estabilidade nos processos de inovação e manufatura, fortalecendo estratégias industriais e atendimento as demandas do Sistema Único de Saúde.
Considering the relation between the economic logic and the necessities of the health area, the study in subject establishes connection the Raw Pharmaceutical Suppliers Qualification’s Work with the productive performance of the Pharmaceutical Industries in the context of the Health Industrial Complex. As objective it evidences the Inter-relationship of administrative, operational and technique orders, front of the articulated performance of the internal Procedures adopted by Farmanguinhos, its processes of Acquisition, Validation, Manufacture and Innovation of Medicines, and the Quality Specified Raw Pharmaceutical acquired, demonstrating inside of this environment, the impact promoted for the Suppliers Qualification’s Work, in compliance with the Good Manufacturing Practices quality requirements. As regulatory and theoretician referential, it bases beyond the economic, politician and institutional capitalist context associated with the production of goods and services of the Health Industrial Complex, the representation of the Pharmaceutical Industry front to the national trade balance and economic development, the connection of conformity between the Validation’s work and the Good Manufacturing Practices, as well as the interdependence enters the specificity of the Raw Pharmaceutical, its public acquisition processes and the supplier qualification works, everything in the scope of the chain of medicine production. The impact of these bases front to the Farmanguinhos administrative, productive and operational technique dynamics is evidenced by deriving information of exploratory research, documentary and of field, used in the intervention methodology. In the field analysis procedures adopted for Farmanguinhos had been evidenced, related with the acquisition for the public administration and with the Raw Pharmaceutical Suppliers Qualification’s Work presenting diagnostics of the raw materials and manufactured medicines disapprove index and its repercussion front to the demand programmed for the Health Ministry. Integrated to the goal of Farmanguinhos operational excellency, the proposal identifies in the Suppliers Qualification, supported for the works of Validation and Acquisitions, stability in the innovation processes and manufactures, fortifying industrial strategies and attendance the demands of the Health System.
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SIE, LING-HUA, and 謝伶華. "Guidance In Good Hygienic Practice Of Soybean Manufacturers At Middle Taiwan Area." Thesis, 2015. http://ndltd.ncl.edu.tw/handle/7mujbf.
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Ambe, Intaher Marcus. "Determining supply chain practices and strategies of light vehicle manufacturers in South Africa." Thesis, 2013. http://hdl.handle.net/10500/8845.
Повний текст джерелаАнотація:
This study determined whether local manufacturers of light vehicles in South Africa employ supply chain best practices and strategies. The research design employed was a combination of exploratory and descriptive research design using qualitative and quantitative approaches based on a survey of light vehicle manufacturers in South Africa. A face-to–face, semi-structured interview questionnaire was used, based on purposive sampling. Descriptive statistics using SPSS software were used for the data analysis and interpretation. The findings of the study revealed that across the supply chain, best practices were implemented to a large extent by all manufacturers. Light vehicle manufacturers in South Africa, however face supply chain challenges, which include technological, infrastructural, cost, market/service and production/skills challenges. The most important supply chain performance indicator that contributes to optimisation of performance is quality, followed by final product delivery reliability, and then cost and supplier reliability.
All the manufacturers followed a lean strategy for their inbound supply chain and some had a lean supply chain strategy for their outbound supply chain. A number of them also had an agile supply chain strategy in the outbound supply chain which suggests a leagile supply chain strategy. It was also found that in some instances there was a mismatch between strategies and practices in the area of product characteristics, manufacturing characteristics and the decision drivers of supply chain. One of the conclusions of the study was that local manufacturers of light vehicles do not always make decisions and implement practices in line with their chosen supply chain strategies. The study concluded by developing a framework for determining supply chain best practices in line with a chosen strategy that could guide supply chain managers (in locally manufactured light vehicles) in the automotive in South Africa in their decision making.Business Management
D. Com. (Business Management)
Книги з теми "Good Manufacture Practice"
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Association, Chilled Food. Guidelines for good hygienic practice in the manufacture of chilled foods. 3rd ed. London: The Association, 1997.
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New Zealand. Ministry of Health. Therapeutics Section., ed. New Zealand code of good manufacturing practice for manufacture and distribution of therapeutic goods. [Wellington, N.Z.]: Ministry of Health, Therapeutics Section, 1995.
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Institute of Food Science and Technology (UK)., ed. Food and drink manufacture: Good manufacturing practice, a guide to its responsible management. London: Institute of Food Science and Technology (UK), 1987.
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Association, Chilled Food, ed. Guidelines for good hygienic practice in the manufacture, distribution & retail sale of chilled foods. 2nd ed. London: Chilled Food Association, 1993.
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Cassie, S. Chemical storage tank systems: Good practice : guidance on design, manufacture, installation, operation, inspection and maintenance. London: Ciria, 2003.
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DeSain, Carol. Documentation basics that support good manufacturing practices. Cleveland, Ohio: Advanstar Communications, 1993.
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DeSain, Carol. Documentation basics that support good manufacturing practices. Eugene, Or: Aster Pub. Corp., 1993.
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European Cosmetic Toiletry and Perfumery Association. and COLIPA, eds. Cosmetic good manufacturing practices: Guidelines for the manufacturer of cosmetic products. Brussels: COLIPA, 1994.
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DeSain, Carol. Documentation basics: That support good manufacturing practices and quality system regulations. 2nd ed. Cleveland, OH: Advanstar Communications, 2001.
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Willig, Sidney H. Good manufacturing practices for pharmaceuticals: A plan for total quality control from manufacturer to consumer. 5th ed. New York: M. Dekker, 2001.
Знайти повний текст джерелаЧастини книг з теми "Good Manufacture Practice"
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Masson, Ron. "Design for Manufacture: Good Practice and its Implementation." In Advances in Manufacturing Technology II, 311–15. Boston, MA: Springer US, 1987. http://dx.doi.org/10.1007/978-1-4615-8524-4_55.
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Delgado, Julio, Claire Roddie, and Michael Schmitt. "Point-of-Care Production of CAR-T Cells." In The EBMT/EHA CAR-T Cell Handbook, 45–49. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-94353-0_8.
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AbstractCAR-T cells for clinical application are classified as advanced therapy medicinal products (ATMPs), and their manufacture is subject to laws and regulations governed by the European Medicines Agency (EMA) and by federal and regional authorities. CAR-T cells must be manufactured to achieve good manufacturing practice (GMP) compliance and are defined as potent products manufactured safely according to standardized methods under closely controlled, reproducible, and auditable conditions. BioPharma supplies the vast majority of CAR-T products for patients, but some academic centres have developed point-of-care cGMP CAR-T manufacturing capability, striving to uphold the same stringency of product quality while improving patient access to CAR-T cells and streamlining the costs of therapy. Point-of-care CAR-T manufacturing can only be performed in facilities with the appropriate regulatory approvals in place.
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McGowan, Neil W. A., John D. M. Campbell, and Joanne C. Mountford. "Good Manufacturing Practice (GMP) Translation of Advanced Cellular Therapeutics: Lessons for the Manufacture of Erythrocytes as Medicinal Products." In Erythropoiesis, 285–92. New York, NY: Springer New York, 2017. http://dx.doi.org/10.1007/978-1-4939-7428-3_18.
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Durá Gil, Juan V., Alfredo Remon, Iván Martínez Rodriguez, Tomas Pariente-Lobo, Sergio Salmeron-Majadas, Antonio Perrone, Calina Ciuhu-Pijlman, et al. "3D Human Big Data Exchange Between the Healthcare and Garment Sectors." In Technologies and Applications for Big Data Value, 225–52. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-78307-5_11.
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Abstract3D personal data is a type of data that contains useful information for product design, online sale services, medical research and patient follow-up.Currently, hospitals store and grow massive collections of 3D data that are not accessible by researchers, professionals or companies. About 2.7 petabytes a year are stored in the EU26.In parallel to the advances made in the healthcare sector, a new, low-cost 3D body-surface scanning technology has been developed for the goods consumer sector, namely, apparel, animation and art. It is estimated that currently one person is scanned every 15 min in the USA and Europe. And increasing.The 3D data of the healthcare sector can be used by designers and manufacturers of the consumer goods sector. At the same time, although 3D body-surface scanners have been developed primarily for the garment industry, 3D scanners’ low cost, non-invasive character and ease of use make them appealing for widespread clinical applications and large-scale epidemiological surveys.However, companies and professionals of the consumer goods sector cannot easily access the 3D data of the healthcare sector. And vice versa. Even exchanging information between data owners in the same sector is a big problem today. It is necessary to overcome problems related to data privacy and the processing of huge 3D datasets.To break these silos and foster the exchange of data between the two sectors, the BodyPass project has developed: (1) processes to harmonize 3D databases; (2) tools able to aggregate 3D data from different huge datasets; (3) tools for exchanging data and to assure anonymization and data protection (based on blockchain technology and distributed query engines); (4) services and visualization tools adapted to the necessities of the healthcare sector and the garment sector.These developments have been applied in practical cases by hospitals and companies of in the garment sector.
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"Contract Manufacture." In Food & Drink - Good Manufacturing Practice, 155–56. Oxford, UK: Wiley-Blackwell, 2012. http://dx.doi.org/10.1002/9781118318225.ch24.
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"Sterile Products Manufacture ‚Äî Basic Principles." In Good Pharmaceutical Manufacturing Practice, 329–70. Informa Healthcare, 2004. http://dx.doi.org/10.1201/9780203489116.ch13.
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"Gmp and Quality Assurance in Sterile Products Manufacture." In Good Pharmaceutical Manufacturing Practice, 371–403. Informa Healthcare, 2004. http://dx.doi.org/10.1201/9780203489116.ch14.
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"CONTRACT MANUFACTURE AND OUTSOURCED PROCESSING AND PACKAGING." In Food and Drink - Good Manufacturing Practice, 239–40. Chichester, UK: John Wiley & Sons, Ltd, 2018. http://dx.doi.org/10.1002/9781119388494.ch33.
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Römhild, Andy. "Good Manufacturing Practice Compliance in the Manufacture of Cell-Based Medicines." In Guide to Cell Therapy GxP, 107–75. Elsevier, 2016. http://dx.doi.org/10.1016/b978-0-12-803115-5.00004-8.
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"Current Good Manufacturing Practices (cGMPs)." In How to Sell Validatable Equipment to Pharmaceutical Manufacturers, 209–44. CRC Press, 1999. http://dx.doi.org/10.1201/b14375-15.
Повний текст джерелаТези доповідей конференцій з теми "Good Manufacture Practice"
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Fernando, Erick, Meyliana, and Surjandy. "Design Business Process Management Model for Pharmaceutical with Good Manufacture Practice and Good Distribution Practice in Indonesia." In International Conferences on Information System and Technology. SCITEPRESS - Science and Technology Publications, 2019. http://dx.doi.org/10.5220/0009907501780183.
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Stoll, Henry W. "Design for Life-Cycle Manufacture." In ASME 1997 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 1997. http://dx.doi.org/10.1115/imece1997-0005.
Повний текст джерелаАнотація:
Abstract As manufacturing companies become more comfortable with the design for manufacture (DFM) philosophy and more experienced in its practice, new opportunities for good design become possible. This paper presents a systematic, easy to use, methodology for applying the DFM philosophy at all stages of the engineering design process. Called design for life-cycle manufacture (DFLC), the approach focuses on three important considerations: (1) the physical concept, (2) the part decomposition, and (3) total product quality. The concept of total product quality is operationalized by decomposing it into three underlying components: quality of concept, quality of design, and quality of ownership. Each of these qualities is the focus of a particular step in the design for life-cycle manufacture methodology.
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Medvedev, Il'ya, and D. Vorotnikov. "PROSPECTS FOR THE USE OF STRUCTURAL MATERIAL BASED ON LOW-VALUE SOFT HARDWOOD WOOD FOR BRIDGES ON HARVESTING ROADS." In Modern machines, equipment and IT solutions for industrial complex: theory and practice. FSBE Institution of Higher Education Voronezh State University of Forestry and Technologies named after G.F. Morozov, 2021. http://dx.doi.org/10.34220/mmeitsic2021_240-244.
Повний текст джерелаАнотація:
Russia has significant reserves of low-value soft deciduous wood (birch, aspen, alder, poplar), which are practically not processed, the wood rots in the forest and in the lower warehouses. Wood is a good and widespread building material. Due to the significant strength, low volume weight, ease of processing, ease of manufacturing and assembly of structures, wood has long been used for the construction of bridges. At present, despite the widespread use of reinforced concrete bridges, in the forest-rich northern and eastern regions of Russia, wooden bridges can be very useful on logging roads. But wooden bridges have a number of significant drawbacks: they have a short service life, are subject to rot, are not fire-resistant, and do not meet the requirements for passing modern loads. In order to ensure the safe and uninterrupted transport of timber on logging roads, special attention should be paid to the construction material for the construction of bridges. The proposed construction material is based on low-value soft hardwood, has high performance characteristics. To improve the performance of the wood, it is necessary to impregnate it-giving it the desired properties and compress it-thereby increasing the density, hardness and strength. We have developed a technology that combines three main technological operations of wood modification: impregnation, pressing and drying, while allowing us to obtain a structural material with increased performance characteristics, suitable for the manufacture of load-bearing supports, as well as beams of wooden bridges on logging roads.
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Dodge, M., S. D. Smith, T. London, K. Sotoudeh, R. Morana, and S. Kabra. "Assessment of Residual Stress and Suitability for Subsea Service of a Welded Superduplex Stainless Steel Flange Joint." In ASME 2016 35th International Conference on Ocean, Offshore and Arctic Engineering. American Society of Mechanical Engineers, 2016. http://dx.doi.org/10.1115/omae2016-54004.
Повний текст джерелаАнотація:
Ferritic-austenitic (duplex) stainless steel components are used for oil and gas production duties due to their high strength and corrosion resistance. The material is routinely used for short flowlines, as well as for welded hubs and flanges. Cathodic protection (CP) is employed, via sacrificial aluminium based anodes, which protects ferritic steel parts from seawater corrosion. Whilst CP has proven successful in preventing corrosion, failures have occurred due to the ingress of electrolytically evolved hydrogen. Duplex stainless steel joints become susceptible to environmental cracking under a combination of high stress, hydrogen content, and susceptible microstructures; critical combinations of which may result in hydrogen induced stress cracking (HISC). Successful operation of duplex equipment, in avoidance of HISC, necessitates a good understanding of the total in-service stresses (including from loading applied in service and from residual stresses from manufacture, fabrication, installation and commissioning). One of the key components of understanding the in-service stress at welds is knowledge of the residual stress distribution, following welding. The focus of this paper is to provide an overview of the typical residual stress levels in a welded superduplex stainless steel (SDSS) subsea joint, using neutron diffraction and finite element modelling. The results are presented in the context of current recommended practice, for example DNV RP-F112.
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He, Cuizhu, and Yinhui Lan. "Research on Martensitic Stainless Steel Used on the Latch Housing of European Pressurized Reactor (EPR) Control Rod Drive Mechanism (CRDM)." In 2022 29th International Conference on Nuclear Engineering. American Society of Mechanical Engineers, 2022. http://dx.doi.org/10.1115/icone29-91786.
Повний текст джерелаАнотація:
Abstract As one of the most important equipment for reactivity control, Control Rod Drive Mechanism (CRDM), which is widely used in Pressurized Water Reactor (PWR) nuclear power plant, has a series of important security functions. As part of the reactor pressure boundary, materials for European Pressurized Reactor (EPR) CRDM pressure housing needs to have relatively high strength and sufficient toughness (i.e., appropriate yield ratio). As an important part of the magnetic circuit, martensitic stainless steel used for latch housing (a part of pressure housing) needs to have good magnetic properties. It is difficult for the yield ratio and the magnetic properties of the materials to meet the specification requirements simultaneously. Based on the design specification, this research refers to the relevant international manufacturing experience and combines the current manufacture with engineering practice. The manufacturing process and key parameters of the material for latching housing of CRDM are established. The martensitic stainless steel which meets the design requirements has been successfully prepared. The comprehensive properties (e.g. yield ratio and magnetic properties) of the material are improved as well. The performance indicators have reached international advanced level. The successful development of the martensitic steel for EPR CRDM latch housing provides strong technical support for the construction of nuclear power projects at home and abroad.
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Lin, Man-Li. "Target costing practice of strategic outsourcing partners: A case study of sporting goods manufacturers." In 2009 IEEE/INFORMS International Conference on Service Operations, Logistics and Informatics (SOLI). IEEE, 2009. http://dx.doi.org/10.1109/soli.2009.5204012.
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MengYao, Tong, and Li FangGang. "The Quality Experience Feedback in Nuclear Fuel Manufacture." In 2018 26th International Conference on Nuclear Engineering. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/icone26-81374.
Повний текст джерелаАнотація:
Experience feedback refers to the timely information collection, transformation, analysis, processing and summary, when some good experience or occasional problems appeared during the manufacturing process. In the manufacturing process of nuclear fuel, CNNC JianZhong Nuclear Fuel Assembly Co., Ltd (CJNF) established a comprehensive experience feedback system, and consolidated experience feedback processing flow. Using classification and gradation to collect, filter, organize and use information. CJNF feeds back some quality problems in fuel assembly manufacture, through the analysis of causes and the implementation of measures to avoid the occurrence of similar problems. Meantime, feeding back and sharing good practical experience in manufacturing and management process, it is benefit to pass on experience and learn from each other. The experience feedback of CJNF is the solid foundation of quality management system’s operation and improvement.
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Uğur, Tuğçe, and Mehmet Sedat Uğur. "Analysing the Effects of Cultural Differences to International Trade in Manufactured Goods: A Literature Survey." In International Conference on Eurasian Economies. Eurasian Economists Association, 2014. http://dx.doi.org/10.36880/c05.01038.
Повний текст джерелаАнотація:
Linder Theory which is a considerable theory about international manufactured goods trade suggests that international trade in manufactured goods will be more intense between countries with similar per capita income levels than between countries with dissimilar per capita income levels. But in practice, cultural differences between countries may also restrain the density of trade. This literature survey will aim to explain the relationship between income level and culture which may be different for one to another group. G. Hofstede who is an influential cultural anthropologist suggests five different cultural dimension to explain cultural differences between countries. Later, Hofstede calculates the values of different countries in these dimensions. So, in this study, initially, international trade in manufactured goods between similar per capital income levels will be examined. This will be done by comparing per capital income levels of selected countries. OECD data in trade and TÜİK's data (for Turkey) will be used in comparison. Later Hofstede's data will be used. In conclusion, the survey will try to explain how large are the effects of cultural differences between countries with similar income levels in international trade in manufactured goods. Previous studies generally find statistically significant results, but the main framework of these studies suggests controversial results. The study has aimed to commit a literature survey and in this study, comparisons of trade flow between countries are also controversial.
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Roy, G. K. "API Standard 616: Scopes for Different Interpretations." In ASME 1995 International Gas Turbine and Aeroengine Congress and Exposition. American Society of Mechanical Engineers, 1995. http://dx.doi.org/10.1115/95-gt-057.
Повний текст джерелаАнотація:
The intention of API standard 616 is to help manufacturer, or buyer of gas turbines in specifying the equipment, and is based on experience and good engineering practices over many years. Like any other standard, the definitions are broad-based to cover possibly the majority of manufacturers, and are based on experiences gathered in the industries in general. However, different interpretations are possible on some of the clauses of the standard. Each gas turbine customer has specific requirements, and the manufacturer’s objective is “Customer Focus” which means it has to fulfill the requirements of the customer totally, or even to take it a step further identify the needs that the customer has not even recognized. The common objective of providing a machine satisfying the specific requirements is difficult to achieve, when attempts are made to bridge the gaps between the customer and the manufacturer through the API standard 616. Few clauses of API standard 616 are controvertial in nature, where possibly more than one explanations are possible, and a more clear guide-line from API is needed to direct the users and the manufacturers. Turbine firing temperature, rotor insensitivity test, API 614, turbine baseplate, post-test bearing inspection, etc are some of them. In this paper these were discussed with some of the available gas turbine purchasing standards. It was concluded that standard like API 616 needs to be general in nature, so that it can be used for each specific customer, however, definitions and its’ scopes need to be clearly identified to avoid mis-use or incorrect use of the standard.
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Machado, Michael, Raul Fangueiro, Daniel Barros, Luís Nobre, João Bessa, Fernando Cunha, João Silva, and João Sousa. "Build Time Analysis of Additive Manufacturing for Next Generation SLS Systems." In ASME 2020 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2020. http://dx.doi.org/10.1115/imece2020-24017.
Повний текст джерелаАнотація:
Abstract With the recent advances in the additive manufacturing (AM) production technologies, AM is becoming more common in today’s industry, nowadays is a normal practice to use this solution either to test a new prototype or to manufacture a functional product. The increase application is mainly due to significant developments in the production solutions of the AM. These recent developments are resulting in an increase search for new and more efficient production solutions. This search is always focused in producing more efficiently, with a greater variety of materials and produce part with better quality and proprieties. From an industrial point of view, one of the types of additive manufacturing that is increasing the percentage of use is the selective laser sintering (SLS) technologies. Although this process was first used in the mid-80’s, it has shown great developments in the recent years. This evolution of the process allowed it to become a solid solution even if it is highly time consuming, especially when compared with other types of addictive manufacturing. From the several aspects that make the SLS a robust solution is the fact that it offers a consistent solution to produce high complex part with good mechanical properties, and also the ability to use many core materials, from polymers, metal alloy, ceramics or even composites materials. Due to the fact that the production of part using SLS technologies takes a long time, shows the relevance to study the entire process in order to quantify the time spent in each stage a very important step. This study can be conducted with two major goals, in one hand to be able to predict the build time needed to complete a predetermined task, and in other hand, to improve the overall efficiency of the process based on the knowledge acquired in the previous analysis. These two aspects are important because they allow the machine operator to choose the production plan more carefully and also to know all the parameters of the process to make it more efficient. In this paper will be presented a survey of the major stages of a SLS process in order to quantify the time consumed in each one of the stages, and if possible, determine solution to reduce the time spent. To better understand the topic the paper will be divided according to the proprieties and time consumed in each of the elements of the process. In other words, it will be divided accordingly to a machine, laser and material point of view. Furthermore, this paper will be focused in the SLS process and the productions based in a polymeric powder, therefore also containing aspects related to the power source used.
Звіти організацій з теми "Good Manufacture Practice"
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Shiihi, Solomon, U. G. Okafor, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Improving the Outcome of GMP Inspections by Improving Proficiency of Inspectors through Consistent GMP Trainings. Purdue University, November 2021. http://dx.doi.org/10.5703/1288284317433.
Повний текст джерелаАнотація:
Approximately 90% of the pharmaceutical inspectors in a pharmacy practice regulatory agency in West Africa have not updated their training on Good Manufacturing Practice (GMP) inspection in at least eight years. However, in the last two years the inspectors relied on learning-on-the job skills. During this time, the agency introduced about 17% of its inspectors to hands-on GMP trainings. GMP is the part of quality assurance that ensures the production or manufacture of medicinal products is consistent in order to control the quality standards appropriate for their intended use as required by the specification of the product. Inspection reports on the Agency’s GMP inspection format in-between 2013 to 2019 across the six geopolitical zones in the country were reviewed retrospectively for gap analysis. Sampling was done in two phases. During the first phase sampling of reports was done by random selection, using a stratified sampling method. In the second phase, inspectors from the Regulatory Agency from different regions were contacted on phone to send in four reports each by email. For those that forwarded four reports, two, were selected. However for those who forwarded one or two, all were considered. Also, the Agency’s inspection format/checklist was compared with the World Health Organization (WHO) GMP checklist and the GMP practice observed. The purpose of this study was to evaluate the reporting skills and the ability of inspectors to interpret findings vis-à-vis their proficiency in inspection activities hence the efficiency of the system. Secondly, the study seeks to establish shortfalls or adequacies of the Agency’s checklist with the aim of reviewing and improving in-line with best global practices. It was observed that different inspectors have different styles and methods of writing reports from the same check-list/inspection format, leading to non-conformances. Interpretations of findings were found to be subjective. However, it was also observed that inspection reports from the few inspectors with the hands-on training in the last two year were more coherent. This indicates that pharmaceutical inspectors need to be trained regularly to increase their knowledge and skills in order to be kept on the same pace. It was also observed that there is a slight deviation in placing sub indicators under the GMP components in the Agency’s GMP inspection format, as compared to the WHO checklist.
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Lubowa, Nasser, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Pharmaceutical Industry in Uganda: A Review of the Common GMP Non-conformances during Regulatory Inspections. Purdue University, December 2021. http://dx.doi.org/10.5703/1288284317442.
Повний текст джерелаАнотація:
The prevalence of substandard medicines in Africa is high but not well documented. Low and Middle-Income Countries (LMICs) are likely to face considerable challenges with substandard medications. Africa faces inadequate drug regulatory practices, and in general, compliance with Good Manufacturing Practices (GMP) in most of the pharmaceutical industries is lacking. The majority of pharmaceutical manufacturers in developing countries are often overwhelmed by the GMP requirements and therefore are unable to operate in line with internationally acceptable standards. Non-conformances observed during regulatory inspections provide the status of the compliance to GMP requirements. The study aimed to identify the GMP non-conformances during regulatory inspections and gaps in the production of pharmaceuticals locally manufactured in Uganda by review of the available 50 GMP reports of 21 local pharmaceutical companies in Uganda from 2016. The binary logistic generalized estimating equations (GEE) model was applied to estimate the association between odds of a company failing to comply with the GMP requirements and non-conformances under each GMP inspection parameter. Analysis using dummy estimation to linear regression included determination of the relationship that existed between the selected variables (GMP inspection parameters) and the production capacity of the local pharmaceutical industry. Oral liquids, external liquid preparations, powders, creams, and ointments were the main categories of products manufactured locally. The results indicated that 86% of the non-conformances were major, 11% were minor, and 3% critical. The majority of the non-conformances were related to production (30.1%), documentation (24.5%), and quality control (17.6%). Regression results indicated that for every non-conformance under premises, equipment, and utilities, there was a 7-fold likelihood of the manufacturer failing to comply with the GMP standards (aOR=6.81, P=0.001). The results showed that major non-conformances were significantly higher in industries of small scale (B=6.77, P=0.02) and medium scale (B=8.40, P=0.04), as compared to those of large scale. This study highlights the failures in quality assurance systems and stagnated GMP improvements in these industries that need to be addressed by the manufacturers with support from the regulator. The addition of risk assessment to critical production and quality control operations and establishment of appropriate corrective and preventive actions as part of quality management systems are required to ensure that quality pharmaceuticals are manufactured locally.
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Kwesiga, Victoria, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Compliance to GMP guidelines for Herbal Manufacturers in East Africa: A Position Paper. Purdue University, November 2021. http://dx.doi.org/10.5703/1288284317428.
Повний текст джерелаАнотація:
With the global increase in the use of traditional and complementary remedies for the prevention and treatment of illness, the quality and safety of these medicines have become a significant concern for all regulatory authorities. Herbal medicines are the most commonly used form of traditional and complementary medicines in the world and the efficacy and safety of herbal medicines, like conventional medicines, largely depends on their quality from planting to harvesting, preprocessing and final processing. Due to the inherent complexity of herbal medicines, often containing an array of active compounds, the primary processing of herbal medicines has a direct influence on their quality. Quality concerns are the reason why the medicines regulatory agencies insist that manufacturers of medicines strictly follow Good Manufacturing Practices since it is an essential tool to prevent instances of contamination, mix-ups, deviations, failures and errors. However, a strict application of GMP requirements is expensive and would drive the prices of the manufactured products up. As a result, a maturity level grading of facilities is proposed as a way of justifying the costs incurred for manufacturers desiring to reach a broader market and investing in continuous improvement. 36 Good Manufacturing Practice (GMP) inspection reports of local herbal manufacturers conducted by National Drug Authority were analyzed to establish the type and extent of deficiencies to GMP requirements for local herbal manufacturers in Uganda. The different GMP chapters and related sub-parameters constituted the variables used for the analysis of conformity to requirements. The primary outcome variable was the conclusion regarding compliance or noncompliance of the inspected local herbal manufacturing facility. GMP parameters that were frequently defaulted by local herbal manufacturers and the corresponding frequencies were identified. The Pearson Chi-square test was applied independently on each category to find the association that existed between conformity and the questions in each category. Only 22% (8) of the 30 inspected facilities were found to comply with GMP requirements, as per National Drug Authority (NDA) guidelines; while the majority of the facilities, 28 (78%), were found not to comply. Of the facilities inspected, 25 were undergoing GMP inspection for the first time. A total of 1,236 deficiency observations were made in the 36 inspection reports reviewed for the study. The mean for all deficiencies was 34.3, and the standard deviation was 15.829. 91.5% of the facilities did not have mechanisms for a record of market complaints; 80.9% did not meet documentation requirements; 78.9% did not have quality control measures in place, and 65.7% did not meet stores requirements. By encouraging a culture of self/voluntary improvement through the introduction of listing of manufacturers based on a maturity level grading, the National Drug Authority will improve the Herbal Medicines sector as per the mandate of improving the herbal medicine industry. Also, increased sensitization of all relevant stakeholders regarding the requirements for GMP should be intensified.
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Agu, Monica, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. The Impact of Mentoring as a GMP Capability Building Tool in The Pharmaceutical Manufacturing Industry in Nigeria. Purdue University, December 2012. http://dx.doi.org/10.5703/1288284317447.
Повний текст джерелаАнотація:
Good Manufacturing Practices (GMP), a component of Pharmaceutical Quality Systems, is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. Provision of adequate number of personnel with the necessary qualifications/practical experience and their continuous training and evaluation of effectiveness of the training is the responsibility of the manufacturer. (World Health Organization [WHO], 2014; International Organization for Standardization [ISO], 2015). The classroom method of training that has been used for GMP capacity building in the pharmaceutical manufacturing industry in Nigeria over the years, delivered by experts from stringently regulated markets, have not yielded commensurate improvement in the Quality Management Systems (QMS) in the industry. It is necessary and long over-due to explore an alternative training method that has a track record of success in other sectors. A lot of studies carried out on mentoring as a development tool in several fields such as academia, medicine, business, research etc., reported positive outcomes. The aim of this study was to explore mentoring as an alternative GMP training method in the pharmaceutical manufacturing industry in Nigeria. Specifically, the aim of this study was to evaluate the impact of mentoring as a GMP capability building tool in the pharmaceutical manufacturing industry in Nigeria, with focus on GMP documentations in XYZ pharmaceutical manufacturing company located in South-Western region of Nigeria. The methodology comprised gap assessment of GMP documentation of XYZ company to generate current state data, development of training materials based on the identified gaps and use of the training materials for the mentoring sessions. The outcome of the study was outstanding as gap assessment identified the areas of need that enabled development efforts to be targeted at these areas, unlike generic classroom training. The mentees’ acceptance of the mentoring support was evident by their request for additional training in some other areas related to the microbiology operations that were not covered in the gap assessment. This result portrays mentoring as a promising tool for GMP capacity building, but more structured studies need to be conducted in this area to generate results that can be generalized.
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Islam, Muhammad Azizul, Pamela Abbott, Shamima Haque, and Fiona Gooch. Impact of Global Clothing Retailers' Unfair Practices on Bangladeshi Suppliers During Covid-19. University of Aberdeen, January 2023. http://dx.doi.org/10.57064/2164/19814.
Повний текст джерелаАнотація:
Based on a survey of 1,000 Bangladeshi factories/suppliers1 producing clothes for global fashion brands and retailers, this research highlights reports of unfair trading practices encountered by manufacturers during Covid-19. Suppliers reported that retailers/brands cancelled orders, refused to pay for goods dispatched/in-process and demanded a reduction in price for orders already placed before March 2020. Since then, they further pressured the suppliers to reduce prices. Suppliers reported that in December 2021, despite the rising costs of inputs and the additional costs of Covid-19 mitigation measures, 70% of brands/retailers were still buying garments at similar prices to those in March 2020 from at least some of their suppliers. More than 50% of factories reported at least one of the following four unfair practices by brands/ retailers: cancellation of orders, price reduction, refusal to pay for goods dispatched/in production and delaying payment of invoices. Such unfair trading practices impacted suppliers’ employment practices resulting in worker turnover, loss of jobs and lower wages. Importantly, one in five factories reported that they had struggled to pay the Bangladeshi legal minimum wages since the factories had reopened following the March and April 2020 lockdown. We recommend countries with large consumer markets where global retailers and brands sell their clothes legislate to curb unfair purchasing practices by outlawing them and appointing an adjudicator or a fashion watchdog. This would ensure that buyers/retailers cannot dump disproportionate and inappropriate risks onto their suppliers and that retailers and brands conform to the norms of fair commercial practices.
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Downes, Jane, ed. Chalcolithic and Bronze Age Scotland: ScARF Panel Report. Society for Antiquaries of Scotland, September 2012. http://dx.doi.org/10.9750/scarf.09.2012.184.
Повний текст джерелаАнотація:
The main recommendations of the panel report can be summarised under five key headings: Building the Scottish Bronze Age: Narratives should be developed to account for the regional and chronological trends and diversity within Scotland at this time. A chronology Bronze Age Scotland: ScARF Panel Report iv based upon Scottish as well as external evidence, combining absolute dating (and the statistical modelling thereof) with re-examined typologies based on a variety of sources – material cultural, funerary, settlement, and environmental evidence – is required to construct a robust and up to date framework for advancing research. Bronze Age people: How society was structured and demographic questions need to be imaginatively addressed including the degree of mobility (both short and long-distance communication), hierarchy, and the nature of the ‘family’ and the ‘individual’. A range of data and methodologies need to be employed in answering these questions, including harnessing experimental archaeology systematically to inform archaeologists of the practicalities of daily life, work and craft practices. Environmental evidence and climate impact: The opportunity to study the effects of climatic and environmental change on past society is an important feature of this period, as both palaeoenvironmental and archaeological data can be of suitable chronological and spatial resolution to be compared. Palaeoenvironmental work should be more effectively integrated within Bronze Age research, and inter-disciplinary approaches promoted at all stages of research and project design. This should be a two-way process, with environmental science contributing to interpretation of prehistoric societies, and in turn, the value of archaeological data to broader palaeoenvironmental debates emphasised. Through effective collaboration questions such as the nature of settlement and land-use and how people coped with environmental and climate change can be addressed. Artefacts in Context: The Scottish Chalcolithic and Bronze Age provide good evidence for resource exploitation and the use, manufacture and development of technology, with particularly rich evidence for manufacture. Research into these topics requires the application of innovative approaches in combination. This could include biographical approaches to artefacts or places, ethnographic perspectives, and scientific analysis of artefact composition. In order to achieve this there is a need for data collation, robust and sustainable databases and a review of the categories of data. Wider Worlds: Research into the Scottish Bronze Age has a considerable amount to offer other European pasts, with a rich archaeological data set that includes intact settlement deposits, burials and metalwork of every stage of development that has been the subject of a long history of study. Research should operate over different scales of analysis, tracing connections and developments from the local and regional, to the international context. In this way, Scottish Bronze Age studies can contribute to broader questions relating both to the Bronze Age and to human society in general.
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Amirav, Aviv, and Steven Lehotay. Fast Analysis of Pesticide Residues in Agricultural Products. United States Department of Agriculture, November 2002. http://dx.doi.org/10.32747/2002.7695851.bard.
Повний текст джерелаАнотація:
The overall theme of this project was to increase the speed of analysis for monitoring pesticide residues in food. Traditionally, analytical methods for multiple pesticides are time-consuming, expensive, laborious, wasteful, and ineffective to meet critical needs related to food safety. Faster and better methods were needed to provide more cost-effective detection of chemical contaminants, and thus provide a variety of benefits to agriculture. This overarching goal to speed and improve pesticide analysis was successfully accomplished even beyond what was originally proposed by the investigators in 1998. At that time, the main objectives of this project were: 1) to further develop a direct sample introduction (DSI) device that enables fast sampling and introduction of blended-only agricultural products for analysis by gas chromatography (GC); 2) to evaluate, establish, and further develop the method of simultaneous pulsed flame photometric detector (PFPD) and mass spectrometry (MS) detection for enhanced pesticide identification capabilities; and 3) to develop a new and novel MS pesticide analysis method, based on the use of supersonic molecular beams (SMB) for sampling and ionization. The first and third objectives were successfully accomplished as proposed, and the feasibility of the second objective was already demonstrated. The capabilities of the GC/SMB-MS approach alone were so useful for pesticide analysis that the simultaneous use of a PFPD was considered superfluous. Instead, the PFPD was investigated in combination with an electron-capture detector for low-cost, simultaneous analysis of organophosphorus and organochlorine pesticides in fatty foods. Three important, novel research projects not originally described in the proposal were also accomplished: 1) development of the quick, easy, cheap, effective, rugged, and safe (QuEChERS) method for pesticides in foods; 2) development and optimization of a method using low-pressure (LP) GC/MS to speed pesticide residue analysis; and 3) innovative application of analyte protectants to improve the GC analysis of important problematic pesticides. All of the accomplishments from this project are expected to have strong impact to the analytical community and implications to agriculture and food safety. For one, an automated DSI approach has become commercially available in combination with GC/MS for the analysis of pesticide residues. Meanwhile, the PFPD has become the selective detector of choice for the analysis of organophosphorus pesticides. Great strides were made in SMB-MS through the manufacture of a prototype "Supersonic GC/MS" instrument, which displayed many advantages over commercial GC/MS instruments. Most notably, the QuEChERS method is already being disseminated to routine monitoring labs and has shown great promise to improve pesticide analytical capabilities and increase lab productivity. The implications of these developments to agriculture will be to increase the percentage of food monitored and the scope of residues detected in the food, which will serve to improve food safety. Developed and developing countries alike will be able to use these methods to lower costs and improve results, thus imported/exported food products will have better quality without affecting price or availability. This will help increase trade between nations and mitigate certain disputes over residue levels in imported foods. The improved enforcement of permissible residue levels provided by these methods will have the effect to promote good agricultural practices among previously obstinate farmers who felt no repercussions from illegal or harmful practices. Furthermore, the methods developed can be used in the field to analyze samples quickly and effectively, or to screen for high levels of dangerous chemicals that may intentionally or accidentally appear in the food supply.