3月29日,WHO发布了第 55 届药物制剂规范专家委员会(ECSPP)技术报告TRSNo.1033,其中发布了以下文件终稿: Annex 1Guidelinesand guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations 附录1 《药物制剂规范专家委员会通过的指南和指导文件》 Annex2Pointsto consider when in...
3月29日,WHO发布了第 55 届药物制剂规范专家委员会(ECSPP)技术报告TRS No.1033,其中包含新的《数据完整性指南》,翻译如下,分享给大家! Guideline on data integrity 数据完整性指南 1. Introduction and background 介绍和背景 1.1. In recent years, the number ofobservations made regarding the integrity of...
Geneva: World Health Organization; 2010: Annex 2 (WHO Technical Report Series No. 957; https://apps.who. int/iris/bitstream/handle/10665/44291/WHO_TRS_957_eng.pdf?sequence=1 , accessed 29 July 2020). 3. WHO Good manufacturing practices for pharmaceutical products: main principles. In: WH...
(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 ...
(TRS 1033 Annex 3, 55th Report)) Background 1. Introductionandscope 2. Background to waterrequirements and uses 3. General principlesfor pharmaceutical water systems 4. Water quality specifications 4.1 Pharmacopoeialspecifications 4.2 Drinking-water...
fifth report 2021 Annex 2 Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation 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 3 / 22 manufactured (e.g. pharmacological classification, activities and properties...
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 ...
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3月29日,WHO发布了第 55 届药物制剂规范专家委员会(ECSPP)技术报告TRS No.1033,其中包含新的《数据完整性指南》,翻译如下,分享给大家! Guideline on data integrity 数据完整性指南 1. Introduction and background 介绍和背景 1.1. In recent years, the number ofobservations made regarding the integrity of...
3月29日,WHO发布了第 55 届药物制剂规范专家委员会(ECSPP)技术报告TRS No.1033,其中包含新的《数据完整性指南》,翻译如下,分享给大家! Guideline on data integrity 数据完整性指南 1. Introduction and background 介绍和背景 1.1. In recent years, the number ofobservations made regarding the integrity of...