Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...
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
WHOTR961A9技术补充文件之六:固定存贮区域的温湿度监测系统1/4QAS/14.598Supplement6Temperatureandhumiditymonitoringsystemsforfixedstorageareas固定存贮区域的温湿度监测系统TechnicalsupplementtoWHOTechnicalReportSeriesNo.961011Annex9:Modelguidanceforthestorage
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...
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_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 ...
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 ...
中英文对照的和原文，请忽略前一份。
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。 The WHOSupplementary guidelines on good manufacturing practice: validation werepublished in 2006andwere supported by seven appendices. The main text (2) and its appendixes (3, 4, 6, 7, 8, 9)...
WHO ECSPP TRS 996 Annex 4 Guidance on Good Manufacturing Practices: Inspection Report 药品生产质量管理规范指南:检查报告 WHO | 2016-06-08 | 双语版 WHO 药品标准专家委员会已关注到修订《药品生产质量管理规范指南:检查报告》(WHO技术报告系列,第908号,附录6,2003)的必要性。本次更新的目的是使其符合目前...