961, 2011 世卫组织技术报告系列,第961号,2011年 Annex 6 附件6 WHO good manufacturing practices for sterile pharmaceutical products 世卫组织无菌药品良好生产规 Introduction 介绍 Following implementation of these WHO good manufacturing practices (GMP) guidelines (1) within the context of the WHO Pre...
WHO TRS 996-ANNEX 05 数据与记录管理规范指南.PDF,Annex 5 Guidance on good data and record management practices Background During an informal consultation on inspection, good manufacturing practices and risk management guidance in medicines’ manufacturin
WHO TRS986 附录 2:WHO 药品 GMP 总则, 2014.pdf,Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and esse
WHO TRS981 附录 2-WHO 质量风险管理指南,2013.pdf,Annex 2 WHO guidelines on quality risk management 1. Introduction 62 1.1 Background and scope 62 1.2 Principles of quality risk management 64 2. Glossary 67 3. Quality risk management process 70 3.1 Initia
Geneva: World Health Organization; 2016: Annex 5 (WHO Technical Report Series, No. 966; https://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex05.pdf, accessed 8 February 2019).8. WHO guidelines on quality risk management. In: WHO Expert Committee on Specifications for ...
Annex 4 - WHO guidelines on good manufacturing practices for blood 热度: 107 ©WorldHealthOrganization WHOTechnicalReportSeries,No.937,2006 Annex4 Supplementaryguidelinesongoodmanufacturing practices:validation 1.Introduction 2.Scope 3.Glossary 4.Relationshipbetweenvalidationandqualification ...
WHO_TRS_962indb17311/8/111:10PM WHOExpertCommitteeonBiologicalStandardizationFifty-seventhreport WHOrecommendationsandguidelines,orproductionandcontrolo,vaccinesandotherbiologicalsarescienti,candadvisoryinnatureandprovideguidance,ornationalregulatoryauthoritiesand,orvaccinemanu,acturers(.who.int/biologicals).Tey,orm...
961, 2011 世界卫生组织技术报告系列,编号961 ,2011 年 Annex 5 附件5 Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms 非无菌制剂的加热通风和空调系统的生产质量管理规范的补充指导原则 目录 1. Introduction...
New WHO Guidelines on the independent lot release of vaccines are also included. Finally, there is an update to the procedure for the prequalif i cation of vaccines.Also included are lists of Recommendations, Guidelines and other documents related to the manufacture and control of biological ...
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