WHO TRS 961 附录6 无菌药品生产质量管理规范-中文.pdf,© World Health Organization 世界卫生组织 WHO Technical Report Series, No. 961, 2011 世卫组织技术报告系列,第961号,2011年 Annex 6 附件6 WHO good manufacturing practices for sterile pharmaceutical pro
WHOTechnicalReportSeries,No.961,2011 Annex14 WHOguidelinesfordraftingasitemasterfile 136 1.Introduction 2.Purpose 3.Scope 4.Contentofsitemasterfile Appendix Contentofasitemasterfile 1 BasedontheExplanatorynotesforpharmaceuticalmanufacturersonthepreparationofasite ...
内容提示: WHO TR961A9 技术补充文件之六:固定存贮区域的温湿度监测系统 1/24 QAS/14.598 Supplement 6 Temperature and humidity monitoring systems for fixed storage areas 固定存贮区域的温湿度监测系统 Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the ...
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...
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 ...
Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...
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12、WHO_TRS_981附录2:WHO质量风险管理指南-英-2013.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Annex2 WHOguidelinesonqualityriskmanagement 1.Introduction62 1.1Backgroundandscope62 1.2Principlesofqualityriskmanagement64 2.Glossary67 3.Qualityriskmanagementprocess70 3.1InitiatingaQRM...
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