1010, Annex 10, 2018. 注:参见WHO技术报告 第1010号附录10《药品活性成分和成品稳定性试验指南》,2018年。 18.1. Where stability determination is initiated by research and developmentorganizations, a written programme should be developed and implemented toinclude elements such as: 研发组织在确定稳定性时,...
Note: For details on cleaning validation, see WHO Technical Report Series, No. 1019, Annex 3, Appendix 3, 2019 and the WHO Points to consider when including HBELs in cleaning validation, TRS XXX, Annex 2, 2021. 注意:有关清洁...
961, 2011 Annex 10 附件 10 Procedure for prequalification of pharmaceutical products 药品的预认证程序1. Introduction 介绍2. Glossary 术语3. Purpose and principles 目的和原则4. Steps of the procedure 程序步骤5. Invitation for expressions of interest 表达兴趣的6. Data and information to be ...
953, Annex 4, 2009 Procedure for prequalification of pharmaceutical products (2011) WHO Technical Report Series, No. 961, Annex 10, 2011 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products (2018) WHO Technical Report Series, No. 1010, Annex 10, 2018 WHO pre...
中英文对照的和原文，请忽略前一份。
1010, Annex 10, 2018. 注:参见WHO技术报告第1010号附录10《药品活性成分和成品稳定性试验指南》,2018年。 18.1. Where stability determination is initiated by research and developmentorganizations, a written programme should be developed and implemented toinclude elements such as: 研发组织在确定稳定性时,...
Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...
eu gmp annex 11 中文 WHO GMP Sterile 2010 Annex 4 TRS957_2010.doc,eu gmp annex 11 中文 WHO GMP Sterile 2010 Annex 4 TRS957_2010 导读:就爱阅读网友为您分享以下“WHO GMP Sterile 2010 Annex 4 TRS957_2010”的资讯,希望对您有所帮助,感谢您对92的支持! Table 2
Thefollowingappendicesincludedinthisannexaddressspecificaspects ofvalidationandareintendedtocomplementthegeneraltextonvalidation: ■Appendix1.Validationofheating,ventilationandair-conditioning systems(ascross-referencetoTRS1010,Annex8(4)) ■Appendix2.Validationofwatersystemsforpharmaceuticaluse ...
WHO_TRS_996_annex09翻译 Annex9 组织机构进行体内生物等效性研究指南 背景 2014年的一场非正式讨论会上，在世界卫生组织（WHO）药学准备 工作规范专家委员会的第49次会议，讨论产生关于可能修正组织机构进 行体内生物等效性研究指南（WHO技术报告系列，No. 937, Annex9, 2006）。WHO药学准备工作规范专家委员会同意...