Littérature scientifique sur le sujet « Good Manufacture Practice »
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Articles de revues sur le sujet "Good Manufacture Practice"
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.
Texte intégralStout, 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 (1 mars 1998) : 169–74. http://dx.doi.org/10.1243/0954405981515581.
Texte intégralBurchett, D. H. « Food and drink manufacture : Good manufacturing practice — a guide to its responsible management ». Food Control 1, no 2 (avril 1990) : 125. http://dx.doi.org/10.1016/0956-7135(90)90098-w.
Texte intégralNatalia, Hernández Jiménez, Ortuño Montero Natalia, Rojas Salas María Fernanda, Chavarría Rojas Marianela, Vargas Zúñiga Rolando et 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 (26 décembre 2021) : 6–19. http://dx.doi.org/10.22270/ijdra.v9i4.494.
Texte intégralLapteva, Natalia, et 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.
Texte intégralStoimenova, Assena H., Bogdan J. Kirilov, Stanislav R. Gueorguiev, Elina S. Petkova-Gueorguieva et Sava G. Ognianov. « Good Manufacturing Practice for Medicinal Products in Bulgaria : an Analysis of Regulatory Inspection Findings ». Folia Medica 62, no 1 (31 mars 2020) : 165–71. http://dx.doi.org/10.3897/folmed.62.e49802.
Texte intégralZhu, Yao Wu, et Yue Xu. « Application of Computer Technology in the Simulation Process of Machine Design ». Applied Mechanics and Materials 481 (décembre 2013) : 217–19. http://dx.doi.org/10.4028/www.scientific.net/amm.481.217.
Texte intégralHuang, Jie, et Hong Jun Liu. « Research and Practice on the End Face Cylindrical Cam NC Machining Technology ». Applied Mechanics and Materials 220-223 (novembre 2012) : 406–9. http://dx.doi.org/10.4028/www.scientific.net/amm.220-223.406.
Texte intégralRafael, Bence, Nóra Kuruczleki et József Gál. « The way of the pharmaceutical ingredients to the finished pharmaceutical form ». Analecta Technica Szegedinensia 12, no 2 (5 décembre 2018) : 24–31. http://dx.doi.org/10.14232/analecta.2018.2.24-31.
Texte intégralGándara, Carolina, Valerie Affleck et 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 (février 2018) : 1–15. http://dx.doi.org/10.1089/hgtb.2017.098.
Texte intégralThèses sur le sujet "Good Manufacture Practice"
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.
Texte intégralTodos 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.
Texte intégralA 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
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.
Texte intégralConsiderando 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.
SIE, LING-HUA, et 謝伶華. « Guidance In Good Hygienic Practice Of Soybean Manufacturers At Middle Taiwan Area ». Thesis, 2015. http://ndltd.ncl.edu.tw/handle/7mujbf.
Texte intégralAmbe, Intaher Marcus. « Determining supply chain practices and strategies of light vehicle manufacturers in South Africa ». Thesis, 2013. http://hdl.handle.net/10500/8845.
Texte intégralBusiness Management
D. Com. (Business Management)
Livres sur le sujet "Good Manufacture Practice"
Association, Chilled Food. Guidelines for good hygienic practice in the manufacture of chilled foods. 3e éd. London : The Association, 1997.
Trouver le texte intégralNew Zealand. Ministry of Health. Therapeutics Section., dir. New Zealand code of good manufacturing practice for manufacture and distribution of therapeutic goods. [Wellington, N.Z.] : Ministry of Health, Therapeutics Section, 1995.
Trouver le texte intégralInstitute of Food Science and Technology (UK)., dir. Food and drink manufacture : Good manufacturing practice, a guide to its responsible management. London : Institute of Food Science and Technology (UK), 1987.
Trouver le texte intégralAssociation, Chilled Food, dir. Guidelines for good hygienic practice in the manufacture, distribution & retail sale of chilled foods. 2e éd. London : Chilled Food Association, 1993.
Trouver le texte intégralCassie, S. Chemical storage tank systems : Good practice : guidance on design, manufacture, installation, operation, inspection and maintenance. London : Ciria, 2003.
Trouver le texte intégralDeSain, Carol. Documentation basics that support good manufacturing practices. Cleveland, Ohio : Advanstar Communications, 1993.
Trouver le texte intégralDeSain, Carol. Documentation basics that support good manufacturing practices. Eugene, Or : Aster Pub. Corp., 1993.
Trouver le texte intégralEuropean Cosmetic Toiletry and Perfumery Association. et COLIPA, dir. Cosmetic good manufacturing practices : Guidelines for the manufacturer of cosmetic products. Brussels : COLIPA, 1994.
Trouver le texte intégralDeSain, Carol. Documentation basics : That support good manufacturing practices and quality system regulations. 2e éd. Cleveland, OH : Advanstar Communications, 2001.
Trouver le texte intégralWillig, Sidney H. Good manufacturing practices for pharmaceuticals : A plan for total quality control from manufacturer to consumer. 5e éd. New York : M. Dekker, 2001.
Trouver le texte intégralChapitres de livres sur le sujet "Good Manufacture Practice"
Masson, Ron. « Design for Manufacture : Good Practice and its Implementation ». Dans Advances in Manufacturing Technology II, 311–15. Boston, MA : Springer US, 1987. http://dx.doi.org/10.1007/978-1-4615-8524-4_55.
Texte intégralDelgado, Julio, Claire Roddie et Michael Schmitt. « Point-of-Care Production of CAR-T Cells ». Dans 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.
Texte intégralMcGowan, Neil W. A., John D. M. Campbell et Joanne C. Mountford. « Good Manufacturing Practice (GMP) Translation of Advanced Cellular Therapeutics : Lessons for the Manufacture of Erythrocytes as Medicinal Products ». Dans Erythropoiesis, 285–92. New York, NY : Springer New York, 2017. http://dx.doi.org/10.1007/978-1-4939-7428-3_18.
Texte intégralDurá 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 ». Dans 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.
Texte intégral« Contract Manufacture ». Dans Food & ; Drink - Good Manufacturing Practice, 155–56. Oxford, UK : Wiley-Blackwell, 2012. http://dx.doi.org/10.1002/9781118318225.ch24.
Texte intégral« Sterile Products Manufacture ‚Äî Basic Principles ». Dans Good Pharmaceutical Manufacturing Practice, 329–70. Informa Healthcare, 2004. http://dx.doi.org/10.1201/9780203489116.ch13.
Texte intégral« Gmp and Quality Assurance in Sterile Products Manufacture ». Dans Good Pharmaceutical Manufacturing Practice, 371–403. Informa Healthcare, 2004. http://dx.doi.org/10.1201/9780203489116.ch14.
Texte intégral« CONTRACT MANUFACTURE AND OUTSOURCED PROCESSING AND PACKAGING ». Dans Food and Drink - Good Manufacturing Practice, 239–40. Chichester, UK : John Wiley & Sons, Ltd, 2018. http://dx.doi.org/10.1002/9781119388494.ch33.
Texte intégralRömhild, Andy. « Good Manufacturing Practice Compliance in the Manufacture of Cell-Based Medicines ». Dans Guide to Cell Therapy GxP, 107–75. Elsevier, 2016. http://dx.doi.org/10.1016/b978-0-12-803115-5.00004-8.
Texte intégral« Current Good Manufacturing Practices (cGMPs) ». Dans How to Sell Validatable Equipment to Pharmaceutical Manufacturers, 209–44. CRC Press, 1999. http://dx.doi.org/10.1201/b14375-15.
Texte intégralActes de conférences sur le sujet "Good Manufacture Practice"
Fernando, Erick, Meyliana et Surjandy. « Design Business Process Management Model for Pharmaceutical with Good Manufacture Practice and Good Distribution Practice in Indonesia ». Dans International Conferences on Information System and Technology. SCITEPRESS - Science and Technology Publications, 2019. http://dx.doi.org/10.5220/0009907501780183.
Texte intégralStoll, Henry W. « Design for Life-Cycle Manufacture ». Dans ASME 1997 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 1997. http://dx.doi.org/10.1115/imece1997-0005.
Texte intégralMedvedev, Il'ya, et D. Vorotnikov. « PROSPECTS FOR THE USE OF STRUCTURAL MATERIAL BASED ON LOW-VALUE SOFT HARDWOOD WOOD FOR BRIDGES ON HARVESTING ROADS ». Dans 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.
Texte intégralDodge, M., S. D. Smith, T. London, K. Sotoudeh, R. Morana et S. Kabra. « Assessment of Residual Stress and Suitability for Subsea Service of a Welded Superduplex Stainless Steel Flange Joint ». Dans 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.
Texte intégralHe, Cuizhu, et Yinhui Lan. « Research on Martensitic Stainless Steel Used on the Latch Housing of European Pressurized Reactor (EPR) Control Rod Drive Mechanism (CRDM) ». Dans 2022 29th International Conference on Nuclear Engineering. American Society of Mechanical Engineers, 2022. http://dx.doi.org/10.1115/icone29-91786.
Texte intégralLin, Man-Li. « Target costing practice of strategic outsourcing partners : A case study of sporting goods manufacturers ». Dans 2009 IEEE/INFORMS International Conference on Service Operations, Logistics and Informatics (SOLI). IEEE, 2009. http://dx.doi.org/10.1109/soli.2009.5204012.
Texte intégralMengYao, Tong, et Li FangGang. « The Quality Experience Feedback in Nuclear Fuel Manufacture ». Dans 2018 26th International Conference on Nuclear Engineering. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/icone26-81374.
Texte intégralUğur, Tuğçe, et Mehmet Sedat Uğur. « Analysing the Effects of Cultural Differences to International Trade in Manufactured Goods : A Literature Survey ». Dans International Conference on Eurasian Economies. Eurasian Economists Association, 2014. http://dx.doi.org/10.36880/c05.01038.
Texte intégralRoy, G. K. « API Standard 616 : Scopes for Different Interpretations ». Dans 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.
Texte intégralMachado, Michael, Raul Fangueiro, Daniel Barros, Luís Nobre, João Bessa, Fernando Cunha, João Silva et João Sousa. « Build Time Analysis of Additive Manufacturing for Next Generation SLS Systems ». Dans ASME 2020 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2020. http://dx.doi.org/10.1115/imece2020-24017.
Texte intégralRapports d'organisations sur le sujet "Good Manufacture Practice"
Shiihi, Solomon, U. G. Okafor, Zita Ekeocha, Stephen Robert Byrn et Kari L. Clase. Improving the Outcome of GMP Inspections by Improving Proficiency of Inspectors through Consistent GMP Trainings. Purdue University, novembre 2021. http://dx.doi.org/10.5703/1288284317433.
Texte intégralLubowa, Nasser, Zita Ekeocha, Stephen Robert Byrn et Kari L. Clase. Pharmaceutical Industry in Uganda : A Review of the Common GMP Non-conformances during Regulatory Inspections. Purdue University, décembre 2021. http://dx.doi.org/10.5703/1288284317442.
Texte intégralKwesiga, Victoria, Zita Ekeocha, Stephen Robert Byrn et Kari L. Clase. Compliance to GMP guidelines for Herbal Manufacturers in East Africa : A Position Paper. Purdue University, novembre 2021. http://dx.doi.org/10.5703/1288284317428.
Texte intégralAgu, Monica, Zita Ekeocha, Stephen Robert Byrn et Kari L. Clase. The Impact of Mentoring as a GMP Capability Building Tool in The Pharmaceutical Manufacturing Industry in Nigeria. Purdue University, décembre 2012. http://dx.doi.org/10.5703/1288284317447.
Texte intégralIslam, Muhammad Azizul, Pamela Abbott, Shamima Haque et Fiona Gooch. Impact of Global Clothing Retailers' Unfair Practices on Bangladeshi Suppliers During Covid-19. University of Aberdeen, janvier 2023. http://dx.doi.org/10.57064/2164/19814.
Texte intégralDownes, Jane, dir. Chalcolithic and Bronze Age Scotland : ScARF Panel Report. Society for Antiquaries of Scotland, septembre 2012. http://dx.doi.org/10.9750/scarf.09.2012.184.
Texte intégralAmirav, Aviv, et Steven Lehotay. Fast Analysis of Pesticide Residues in Agricultural Products. United States Department of Agriculture, novembre 2002. http://dx.doi.org/10.32747/2002.7695851.bard.
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