《生产记录的数据可靠性指南》-ISPE

逍途 · 发表于 2020-3-1 14:56:42

谢谢提供分享

五月蔷薇1983 · 发表于 2020-3-3 12:51:35

有原文吗？或链接

normal · 发表于 2020-4-1 12:54:47

哪里可以下载？

苏杰上善若水 · 发表于 2020-4-1 13:31:08

只有目录，没有附件，差评

JOO · 发表于 2020-4-2 10:19:46

我有英文版

求交换其他ISPE文件：1. Records & Data Integrity
2. Electronic Data Archiving
3. A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
4. A Risk-Based Approach to GxP Process Control Systems (Second Edition)
5. IT Infrastructure Control and Compliance (Second Edition)
6. Manufacturing Execution Systems – A Strategic and Program Management Approach
7. A Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP 5
8. A Risk-Based Approach to Testing of GxP Systems (Second Edition)
9. GAMP RDI GPG: Data Integrity - Key Concepts
10. Commissioning & Qualification of Pharma Water & Steam Systems (Second Edition)
11. Comparator Management
12. Controlled Temperature Chamber Mapping & Monitoring
13. Decommissioning Pharma Equipment & Facilities
14. HVAC & Process Equipment Air Filters
15. Interactive Response Technology
16. Maintenance
17. Management of Engineering Standards
18. Operations Management
19. Packaging, Labeling, and Warehousing Facilities
20. Process Validation
21. Quality Laboratory Facilities
22. Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement - Part 4
23. Handbook: Sustainability
24.Japan Affiliate: Pest Control Manual（虫害我有第二版中英文，求最新版）
25. D/A/CH Affiliate: Containment Manual

xuanzhuan · 发表于 2020-4-2 11:10:34

期待原文，谢谢~~~~~

凡9731cacf · 发表于 2020-4-4 09:42:33

能传送一下全文学习一下吗？

凡9731cacf · 发表于 2020-4-11 08:16:39

有原文吗，传上来，共享学习。谢谢！

xxxy2009 · 发表于 2020-7-1 10:07:05

好好学习，天天向上

llwowen · 发表于 2020-7-1 16:02:23

感谢楼主无私分享

simonpeng1101 · 发表于 2020-10-14 11:34:41

好好学习，天天向上

吴玉冬 · 发表于 2021-2-22 19:36:02

感谢楼主分享

阿狸1234 · 发表于 2021-2-23 13:54:27

感谢楼主也感谢楼下分享链接的

eggsgo · 发表于 2022-5-18 11:06:23

多谢分享~~

NAkklecwux · 发表于 2022-5-18 11:28:24

谢谢分享，请问在哪里能看到内容？

leiyang610 · 发表于 2022-5-18 12:03:53

https://www.ouryao.com/forum.php ... facturing%2BRecords

小金库 · 发表于 2022-8-2 21:48:34

感谢分享，先收藏

[翻译交流] 《生产记录的数据可靠性指南》-ISPE