资料分享|WHO_TRS_1025 2020

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WHO刚刚发布2020年TRS 1025,共345页,其中包括13个附录,均为相关技术或管理的指南。 

 

附录目录如下:
Annex 1 Procedure for the elaboration, revision and omission of monographs and other texts for The International Pharmacopoeia
附录1:国际药典各论和其它内容的起草、修订和删除
Annex 2 International Atomic Energy Agency and World Health Organization guideline on good manufacturing practices for radiopharmaceutical products
附录2:国际原子能机构(IAEA)和世界卫生组织(WHO)放射性药品优良生产规范指南
Annex 3 Production of water for injection by means other than distillation
附录3:非蒸馏方法制备注射用水
Annex4 Good chromatography practices
附录4:优良色谱规范
Annex 5 Quality management system requirements for national inspectorates
附录5:国家检查组的质量管理体系要求
Annex 6 Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance
附录6:生产商和检查员考量要点:防止抗生素耐药性的生产环境考量
Annex 7 Good storage and distribution practices for medical products
附录7:药品优良存贮和运输规范
Annex 8 Points to consider for setting the remaining shelf-life of medical products upon delivery
附录8:设置药品发货时剩下货架期的考量要点
Annex 9 World Health Organization/United Nations Population Fund Prequalification Programme guidance for contraceptive devices: male latex condoms, female condoms and intrauterine devices
附录9:世界卫生组织(WHO)/联合国人口基金预认证计划避孕工具指南:男用乳胶避孕套、女用避孕套和宫内节育器
Annex 10 World Health Organization/United Nations Population Fund technical specifications for male latex condoms
附录10:世界卫生组织(WHO)/联合国人口基金男用乳胶避孕套技术规范
Annex 11 World Health Organization/United Nations Population Fund specifications for plain lubricants
附录11:世界卫生组织(WHO)/联合国人口基金普通润滑剂技术规范
Annex 12 WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
附录12:WHO“生物豁免清单”:WHO基本药物速释、固体口服剂型模型清单中体内生物等同性要求豁免提议
Annex 13 WHO guideline on the implementation of quality management systems for national regulatory authorities
附录13:WHO国家药监当局质量管理体系实施指南

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WHO_TRS_1025 2020.rar

发布于 2020-04-30 09:10

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