WHO最新技术指南

joseph666 · 发表于 2021-3-31 11:21:35

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HBEL,数据完整性，制药用水等11指南文件

罗伊鲱 · 发表于 2021-3-31 20:28:18

本帖最后由厕所所长于 2021-3-31 19:35 编辑

你这个比官方发布还快！
附录：
Annex 1  Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations
Annex 2  Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation
Annex 3  Good manufacturing practices: water for pharmaceutical use
Annex 4  Guideline on data integrity
Annex 5  World Health Organization/United Nations Population Fund Recommendations for condom storage and shipping temperatures
Annex 6  World Health Organization/United Nations Population Fund Guidance on testing of male latex condoms
Annex 7  World Health Organization/United Nations Population Fund guidance on conducting post-market surveillance of condoms
Annex 8  WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
Annex 9  Guidelines on the implementation of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce
Annex 10 Good reliance practices in the regulation of medical products: high level principles and considerations
Annex 11 Good regulatory practices in the regulation of medical products

wsx · 发表于 2021-4-1 15:45:50

产品不出口，坚决不参考

TIANWENBEI · 发表于 2021-3-31 11:57:41

感谢分享！

mxye2005 · 发表于 2021-3-31 11:40:47

谢谢分享！

wgx1979 · 发表于 2021-3-31 12:45:21

感谢分享！

maotingbi · 发表于 2021-3-31 13:31:05

谢谢分享！

empty1983 · 发表于 2021-3-31 13:43:52

谢谢楼主分享！！！

shuspecial2003 · 发表于 2021-3-31 13:46:21

感谢分享！

﹏soゝ繆斯 · 发表于 2021-3-31 14:30:17

全英文的累

奕迪帅娃 · 发表于 2021-3-31 15:30:48

谢谢分享！

菜菜宝贝 · 发表于 2021-3-31 15:39:46

谢谢分享！

lgnllhp · 发表于 2021-3-31 15:57:08

谢谢分享！

过路路过 · 发表于 2021-3-31 16:07:05

谢谢分享

wyl0511 · 发表于 2021-3-31 16:40:14

谢谢分享，码了学习

果粒橙12 · 发表于 2021-3-31 21:30:53

求中文，求中文。求中文

来自安卓APP客户端

lzliu · 发表于 2021-4-1 08:46:49

谢谢分享，学习了

owenyx_1981 · 发表于 2021-4-1 08:56:37

谢谢分享！

hnlhqa · 发表于 2021-4-1 09:02:17

等大神翻译

gezi2480 · 发表于 2021-4-1 09:05:59

谢谢分享~~

ilovesummerwy · 发表于 2021-4-1 09:42:44

谢谢分享，很有用

[GMP相关] WHO最新技术指南

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