Validation of heating, ventilation and air-conditioning systems (as cross-reference to TRS 1010, Annex 8 (4))■ Appendix 2. Validation of water systems for pharmaceutical use (as published in TRS 937, Annex 4, 2006 and as cross-reference to TRS 970, Annex 2, 2012(5)■ Appendix 3. ...
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...
Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...
1019,Annex 3, Appendix 3, 2019 and the WHO Points to consider when including HBELsin cleaning validation, TRS XXX, Annex 2, 2021. 注:有关清洁验证的详细信息,请参阅WHO技术报告系列第1019号,附录3,2019和WHO《清洁验证中应用HBEL的考量》,TRS XXX,附录2,2021。 22.1. Research and development ...
Annex8 Proposaltowaiveinvivobioequivalence requirementsforWHOModelListofEssential Medicinesimmediate-release,solidoraldosageforms Introduction 1.Background 2.WHOrevisionstothecriteriaforBiopharmaceuticsClassificationSystem classification 3.WHOextensionstothescopeofapplicationofthebiowaiver ...
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_937__annex8_eng ? World Health Organization WHO Technical Report Series, No. 937, 2006 Annex 8 Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms Introduction 1. 2. 3. 4. 5. 6. Background WHO ...
1019,Annex 3, Appendix 3, 2019 and the WHO Points to consider when including HBELsin cleaning validation, TRS XXX, Annex 2, 2021. 注:有关清洁验证的详细信息,请参阅WHO技术报告系列第1019号,附录3,2019和WHO《清洁验证中应用HBEL的考量》,TRS XXX,附录2,2021。 22.1. Research and development ...
301Annex 8Points to consider for setting the remaining shelf-life of medical products upon deliveryEdit and republication of Points to consider for setting the remaining shelf-life of medical products upon delivery, WHO Technical Report Series No. 1025, Annex 8, with a new Appendix 2.Background...
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