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
附录2世界卫生组织(WHO)药品GMP主要原理 WorldHealthOrganizationWHOTechnicalReportSeries,No.986,2014世界卫生组织技术报告系列,编号986,2014年 编辑整理:Nancy2016.03.222 目录 Annex2WHOgoodmanufacturingpracticesforpharmaceuticalproducts:mainprinciples附录2世界卫 ...
WHO_TRS_961 Annex2WHO药品微生物实验室管理规范 下载积分: 1000 内容提示: WHO 技术指南报告 No. 961, 2011, annex 2 WHO 药品微生物实验室管理规范 1 of 27 © World Health Organization 世界卫生组织 WHO Technical Report Series, No. 961, 2011 世界卫生组织技术报告系列,编号961 ,2011 年 Annex 2 ...
Annex 2 63 While the choice o the tools to support the QRM approach is optional and may vary, the tools chosen need to be appropriate or the intended use. In return or using this approach, there are potential opportunities or both MRAs and pharmaceutical manu acturers (8) as summarized in...
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
Annex3附录3 WHOgoodmanufacturingpracticesforbiologicalproducts WHO生物制品生产质量管理规范(GMP) 1 ReplacementofAnnex1ofWHOTechnicalReportSeries,No.822 代替WHO技术报告系列(TRS)822号附录1 1.Introduction简介6 2.Scope范围7 3.Terminology术语13 4.Principlesandgeneralconsiderations原则与总论23 5.Pharmaceutical...
近⽇，WHO发布了新的清洁验证指南——《不同⽅法——包括HBEL——建⽴清洁验证的残留 限度以确定共⽤设施⽣产污染风险的考量》，该指南解读如下：传统的⽅法是进⾏清洁验证并基于GMP⽂件中建议的接受标准来判断清洁程序的适⽤性。这种 做法可能不再是可以接受的和合理的，因为没有考虑到HBEL。鉴于...
The World Health Organization (WHO) has published the guideline entitledGood ManufacturingPractices for pharmaceutical products: main principlesin the WHO Technical Report Series, No. 986, Annex 2, 2014(1). WHO于2014年TRS 986附录2发布了题为“药品GMP:主则”的指南。
Annex 1 附录1 1. Introductionand background 介绍及背景 The World HealthOrganization (WHO) has published the guideline entitled Good manufacturing practicesfor pharmaceutical products: main principles in the WHO Technical ReportSeries, No. 986, Annex 2, 2014 (1). WHO 于 2014 年 TRS 986 附录2 ...
WHO TRS 1022 第55 次 报告 Annex 3 Good manufacturing practices: water for pharmaceutical use 优良生产规范( GMP ): 制药用水 Background 背景 Unlike other product or process ingredients, water is usually drawn from an on demand system and is not subject to testing and batch or lot release ...