EMA Q&A FOR ICH guideline Q7

BH160217

这个问答还是很不错的，解释了很多被自由解释的东西。。。有需要的可以来个学习了解。
Table of contents
Preface........................................................................................................ 3
1. Introduction – Scope...............................................................................4
2. Quality Management................................................................................ 5
3. Personnel ................................................................................................ 7
4. Buildings and Facilities – Containment.................................................... 7
5. Process Equipment – Cleaning................................................................. 9
6. Documentation and Records.................................................................. 11
7. Materials Management .......................................................................... 13
8. Production and In-Process Controls ...................................................... 15
9. Packaging and Identification Labelling of APIs and Intermediates ....... 16
10. Storage and Distribution ..................................................................... 16
11. Laboratory Controls............................................................................. 18
12. Validation ............................................................................................ 21
13. Change Control.................................................................................... 22
14. Rejection and Reuse of Materials......................................................... 22
15. Complaints and Recalls........................................................................ 23
16. Contract Manufacturers (including Laboratories) ................................ 24
17. Agents, Brokers, Traders, Distributors, Repackers, and Relabellers .... 25
18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation
.................................................................................................................. 27
19. APIs for Use in Clinical Trials............................................................... 28
20. Glossary .............................................................................................. 28
21. References .......................................................................................... 29
22. Annex: Q&As linked to the respective sections of ICH Q7................... 31

大同

谢谢你们给予我的信息

胜利者

顶起

杯子里的猫

很值得借鉴

kc1711422001

Thanks for sharing

一沙一叶

这个可以组织一起翻译一下

BH160217

一沙一叶 发表于 2016-5-30 19:24
这个可以组织一起翻译一下

倒是可以 不过就是不知道有没有这个需要和必要呢