WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-fifth report Annex 3 Good manufacturing practices: water for pharmaceutical use WHO TRS 1033 附录 3 GMP:制药用水 2021 译文仅供参考 翻译:JULIA 页 1 / 26 Annex 3 附录 3 Good manufacturing practices: water for pharmaceutical ...
例如2022年12月22日所发布的最新TRS,其编号为TRS 1044,按照ECSPP的说明是其第56次会议的技术报告;而之前第55次ECSPP会议的技术报告,其编号则是TRS 1033,发布时间为2021年3月25日;往回追溯第54次ECSPP会议的技术报告,其编号则是TRS 1025,发布时间为2020年4月21日。 又例如,WHO在2016年发布的TRS999 ANNEX2,...
Geneva: World Health Organization; 2020: Annex 3 (WHO Technical Report Series, No. 1025; https://www.who.int/docs/default -source/medicines/who -technical -report -series -who -expert -committee -on-specifications -for -pharmaceutical -preparations/trs1025 -annex3.pdf?sfvrsn= caebed51_2 ,...
(HBELs) in cleaning validation Annex 2 附录2 Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation 清洁验证中包括基于健康的暴露限（HBEL）时的考虑要点 WHO TRS 1033 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1 / 22 ...
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.Scope 范围 3.Glossary 术语 4.Data ...
WHO TRS1033 附录2 清洁验证考虑要点 中英.pdf,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
内容提示: 135Annex 4Guideline on data integrityT h is document replaces the WHO Guidance on good data and record management practices (Annex 5, WHO Technical Report Series, No. 996, 2016) (1).1. Introduction and background 1372. Scope 1373. Glossary 1384. Data governance 1405. Quality ...
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
Annex3,2015(3)). 119 WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparationsFifty-thirdreport 1.Introduction121 2.Scope121 3.Glossary122 4.Relationshipbetweenvalidationandqualification124 5.Validation124 6.Documentation125 7.Validationmasterplan126 ...
Annex2 WHOguidelinesonqualityriskmanagement 1.Introduction62 1.1Backgroundandscope62 1.2Principlesofqualityriskmanagement64 2.Glossary67 3.Qualityriskmanagementprocess70 3.1InitiatingaQRMprocess70 3.2PersonnelinvolvedinQRM70 3.3Knowledgeoftheproductandprocess71 ...