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
Annex2 WHOgoodmanuacturingpracticesorpharmaceutical products:mainprinciples 1 Introduction79 Generalconsiderations80 Glossary81 Qualitymanagementinthemedicinesindustry:philosophyand essentialelements85 1.Pharmaceuticalqualitysystem85 Qualityriskmanagement88 Productqualityreview88 2.Goodmanuacturingpracticesorpharmaceuticalprod...
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 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
Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...
又例如,WHO在2016年发布的TRS999 ANNEX2,就是针对生物制品的GMP原则,而针对化药相关的GMP原则,则有TRS986 ANNEX2(主要原则,2014)、TRS957 ANNEX2(原料药GMP)、TRS1044 ANNEX2(无菌产品,已参照EU GMP修订后的ANNEX1在原指南- TRS961 ANNEX6基础上进行了较大修订)等,与之配套,WHO还发布了大量与GMP相关的其它...
WHO Technical Report Series, No. 970, 2012 Annex 2 附件2Page 1 of 20 Annex 2 附件2 WHO good manufacturing practices: water for pharmaceutical use WHO GMP：制药用水 1. Introduction 介绍 1.1 Scope of the document文件范围 1.2 Background to water requirements and uses 水的要求和使用背景...
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 TRS1019 附录 3-GMP 验证指南,附录 5,计算机化系统的验证,2019.pdf,Annex 3 Good manufacturing practices:guidelines onvalidation Background The need for revision of the published World Health Organization (WHO) Supplementary guidelines on good manufact
WHO TRS1033 附录2 清洁验证中包括基于健康的暴露限(HBEL)时的考虑要点 中英 WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-fifth report 2021 Annex 2 Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation Annex 2 附录2 Points to ...