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_TRS_986_2014 下载积分: 2000 内容提示: W H O T e c h n i c a l R e p o r t S e r i e s986Forty-eighth reportWHO Expert Committee on Specifications for Pharmaceutical PreparationsWHO Expert Committee on Specif i cations for Pharmaceutical Preparations 986 WHO Technical Report ...
王艳艳 WHO_TRS_986-Annex2 WHO GMPfor pharmaceutical products-main principles 下载文档 收藏 打印 转格式 1698阅读文档大小:323.23K69页nancyluck0721上传于2016-03-23格式:PDF WHO_TRS_961-Annex 3 WHO GMP for pharmaceutical products-main principles童静20121221 ...
WHO于2014年TRS986附录2发布了题为“药品GMP:主则”的指南。WHO的“GMP补充指南:验证”于2006年发布,有7个附录作为⽀持⽂件。该 主⽂件及其附录于2006到2019年之间进⾏了修订。与清洁验证有关的附录3当时未更新。但在2019年7⽉瑞⼠⽇内⽡的⾮正式沟通期间对其修订进⾏了 ...
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
WHO TRS 996 附录3 生物制品良好生产质量规范-中文.pdf,Annex 3 附件 3 WHO good manufacturing practices for biological products 世卫组织生物制品良好生产规范 1 Replacement of Annex 1 of WHO Technical Report Series, No 822 替换世界卫生组织技术报告系列第 822 号
Geneva: World Health Organization; 2014: Annex 2 (WHO Technical Report Series, No. 986 https://apps.who.int/iris/bitstream/handle/10665/112733/WHO_TRS_986_eng.pdf?sequence=1 , accessed 29 July 2020). 4. The International Pharmacopoeia . Geneva, World Health Organization ( https://www.who...
WHO_TRS_996_annex09翻译 Annex9 组织机构进行体内生物等效性研究指南 背景 2014年的一场非正式讨论会上，在世界卫生组织（WHO）药学准备 工作规范专家委员会的第49次会议，讨论产生关于可能修正组织机构进 行体内生物等效性研究指南（WHO技术报告系列，No. 937, Annex9, 2006）。WHO药学准备工作规范专家委员会同意...
在查找WHO的法规过程中，发现所有的指南都是以附件形式出现在TRS的后面。查找比较困难。因此，自己将WHO ...
Guideline on data integrity 数据完整性指南 This document replaces the WHO Guidance on good data and record management practices (Annex 5, WHO Technical Report Series, No. 996, 2016) (1).本文取代WHO优良数据和记录管理规范指南（WHO TRS 996附录5，2016）1.Introduction and background 前言和背景 2...