WHOTRS986-ANNEX2Materials物料 1 Materials Objectives目的 Toreviewspecificrequirementsforeachtypeofmaterial:Startingmaterials起始物料（原料、辅料）Packagingmaterials包装材料Intermediateandbulkproducts中间体和半成品Finishedproducts成品Rejectedandrecoveredmaterials拒收和返工物料Recalledproducts召回...
Annex2WHOgoodmanufacturingpracticesfor pharmaceuticalproducts:mainprinciples 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...
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 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 WHOguidelinesonqualityriskmanagement 1.Introduction62 1.1Backgroundandscope62 1.2Principlesofqualityriskmanagement64 2.Glossary67 3.Qualityriskmanagementprocess70 3.1InitiatingaQRMprocess70 3.2PersonnelinvolvedinQRM70 3.3Knowledgeoftheproductandprocess71 ...
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.Pharmaceuticalqualitysystemandqualityriskmanagement药物质量体系与 ...
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 ...
Annex3,2015(3)). 119 WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparationsFifty-thirdreport 1.Introduction121 2.Scope121 3.Glossary122 4.Relationshipbetweenvalidationandqualification124 5.Validation124 6.Documentation125 7.Validationmasterplan126 ...
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...
WHOTRS1033附录2清洁验证包括基于健康的暴露限(HBEL)时的考虑要点译文仅供参考翻译:JULIA页2/22 1.Introductionandbackground介绍与背景 TheWorldHealthOrganization(WHO)haspublishedtheguidelineentitledGoodmanufacturing practicesforpharmaceuticalproducts:mainprinciplesintheWHOTechnicalReportSeries,No. 986,Annex2,2014(1)....