pe-009-17-gmp-GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART I医药产品操作规程第一部分.docx,PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME 25 August 2023PE 009- 17 (Part I 25 August 2023 PE 009- 17 (P
In 1989, the EU adopted its own GMP Guide, which - in terms of GMP requirements - was equivalent to the PIC/S GMP Guide. Since that time, the EU and the PIC/S GMP Guides have been developed in parallel and whenever a change has been made to one, the other has been amended so th...
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PIC/SGMP从2021年的15版，到2022年EU GMP附录1更新后的16版，再到这一次刚刚发布的17版，很频繁，...
不过很可惜，官译审核版目前还是以PICS PE 009-15 GMP Guide为准，即2021年5月1日的版本。目前的初审...
您需要登录才可以下载或查看，没有帐号？立即注册 x 截至目前最新的PIC/S指南 PE 009-15GMPGuide2021...
Revision of PIC/S GMP Guide (PE 009-14) PIC/S GMP指导原则(PE 009-14)修订版 Geneva, 20 June 2018: the following Chapters and Annex of the PIC/S GMP Guide have been revised: 2018.6.20 日内瓦:以下PI...
specifictothe EU GMP Guide and has not been adopted by PIC/S.** The EUfirstadoptedthe ICH GMPGuideonAPIsasAnnex 18tothe EU GMPGuidewhi le PIC/S adopted it as a stand-alone GMP Guide(PE 007).The Guide has now been adopted as Part I I of the PIC/SGMP Guide(see PE 009(Part I ...
The Guide has now been adopted as Part II of the PIC/S GMP Guide (see PE 009 (Part II)). 欧盟首先采用了ICH GMP原料药指南作为欧盟GMP指南的附件18,但PIC/S将其作为单独的GMP指南(PE 007)。该指南目前成为PIC/S GMP指南的第II部分(参见PE 009第II部分)...
PIC/S PE009-10(Annexes)药品GMP指南附件11 计算机系统 PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPEC TION CO-OPERATION SCHEME PE 009-10 (Annexes) 1 January 2013 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 药品GMP指南 ANNEXES 附件 ANNEX 11 附件11 COMPUTERISED SYSTEMS 计算机系统...