又例如,WHO在2016年发布的TRS999 ANNEX2,就是针对生物制品的GMP原则,而针对化药相关的GMP原则,则有TRS986 ANNEX2(主要原则,2014)、TRS957 ANNEX2(原料药GMP)、TRS1044 ANNEX2(无菌产品,已参照EU GMP修订后的ANNEX1在原指南- TRS961 ANNEX6基础上进行了较大修订)等,与之配套,WHO还发布了大量与GMP相关的其它...
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
Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...
953, 2009, Annex 2 (9) WHO Technical Report Series No. 986, 2014 Drug product (or finished pharmaceutical product (FPP)) (name, dosage form) 3.2.P.1 Description and composition of the FPP (name, dosage form) 3.2.P A description of the FPP and its composition should be provided. The...
Annex2 WHOguidelinesonqualityriskmanagement 1.Introduction62 1.1Backgroundandscope62 1.2Principlesofqualityriskmanagement64 2.Glossary67 3.Qualityriskmanagementprocess70 3.1InitiatingaQRMprocess70 3.2PersonnelinvolvedinQRM70 3.3Knowledgeoftheproductandprocess71 ...
Geneva: World Health Organization; 2014: Annex 2 (WHO Technical Report Series, No. 986 https://apps.who.int/iris/bitstream/handle/10665/112733/WHO_TRS_986_eng.pdf?sequence=1 , accessed 29 July 2020). 4. The International Pharmacopoeia . Geneva, World Health Organization ( https://www.who...
王艳艳 WHO_TRS_986-Annex2 WHO GMPfor pharmaceutical products-main principles 下载文档 收藏 打印 转格式 1698阅读文档大小:323.23K69页nancyluck0721上传于2016-03-23格式:PDF WHO_TRS_961-Annex 3 WHO GMP for pharmaceutical products-main principles童静20121221 ...
Annex3,2015(3)). 119 WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparationsFifty-thirdreport 1.Introduction121 2.Scope121 3.Glossary122 4.Relationshipbetweenvalidationandqualification124 5.Validation124 6.Documentation125 7.Validationmasterplan126 ...
Annex 2 Points to consider when including Health-Based Exposure Limits (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...
986,Annex2,2014(1). WHO已在2014年WHO第986号技术报告附录2发布了题为《药品GMP:主要原则》的指南. TheWHOSupplementaryguidelinesongoodmanufacturingpractice:validationwerepublishedin 2006andweresupportedbysevenappendices.Themaintext(2)anditsappendixes(3,4,6,7,8, 9)wererevisedbetween2006and2019.Appendix3,re...