908, 2003Annex 9Guide to good storage practices forpharmaceuticals11.Introduction1252.Glossary1263.Personnel1284.Premises and facilities1285.Storage requirements1316.Returned goods1337.Dispatch and transport1338.Product recall134References134Bibliography134Appendix136Storage and labelling conditions1.IntroductionThis ...
961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products August 2014 WHO 第第 961 号技术报告 附录 9 :时间和温度敏感的药品的贮运指南技术补充之 温控存贮区的确认 World Health Organization 2014 WHO Press, World Health Organization, 20...
WHO_TRS_908-Annex9 ? World Health Organization WHO Technical Report Series, No. 908, 2003 Annex 9 Guide to good storage practices for pharmaceuticals1 1. 2. 3. 4. 5. 6. 7. 8. Introduction Glossary Personnel Premises and facilities Storage requirements Returned goods Dispatch and transport ...
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...
who_trs_996_annex09翻译.pdf,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, A
3月29日,WHO发布了第 55 届药物制剂规范专家委员会技术报告TRS No.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》 ...
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...
[7] WHO. Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases[EB/OL]. (2021-07-22)[2021-10-05]. https://www. who.int/publications/m/item/annex-3-mRNA-vaccines-trsno-1039. ...
Non-sterile process validation (as published in TRS 992, Annex 3, 2015 (3)). 1. Introduction介绍1.1 Validation is an essential part of good practices, including good manufacturing practices (GMP) (6) and good clinical practices (GCP). It is therefore an element of the pharmaceutical quality...
Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...