| 查看: 193 | 回复: 1 | |||
| 【奖励】 本帖被评价1次，作者wu9820168增加金币 1 个 | |||
| 当前主题已经存档。 | |||
[资源]
APIC(ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE) 指南免费下载
|
|||
|
In this section you will find all the publications prepared by APIC. Those documents can be downloaded as a pdf file. APIC list of Abbreviations & Acronyms Industry Best Practice documents: Good Manufacturing Practices for Active Ingredients Manufacturers, with EFPIA, 1996 Quality System for Active Ingredients Manufacturers, integrating GMP into ISO, 1997 Manufacture of Sterile Active Pharmaceutical Ingredients, guidance, 1999 Cleaning validation in Active Ingredient Manufacturing plants – Policy, 1999 Good manufacturing practices in Active Pharmaceutical Ingredients development, 1999 Cleaning validation in active pharmaceutical plants – guidance, 2000 "How to do" - Interprétation of ICH Q7A document & "Review Form" Computer Validation Guide, December 2002 Auditing Guide, August 2002 Appendix A - Auditing Guide Secrecy Agreement Appendix B - Auditing Guide Questionnaire Appendix C - Auditing Guide Aide Mémoire Appendix D - Auditing Guide Audit Report Template Audit Programme, September 2006 Parametric release document, December 2002 Qualification of existing equipment 2004 Technical Change Control Guideline 2004 Quality Management System (QMS) for APIs 2005 Disclaimer: These documents represent the views of APIC members only and do not constitute a formal regulatory guidance. http://www.apic.cefic.org/publications/publications.html |
回复此楼» 猜你喜欢
为什么网上很多人说本周 12号出结果
已经有4人回复
-
基金中了
已经有15人回复
-
帮忙看看fileCode
已经有8人回复
-
小木虫上这么多卖论文的，真有人买论文么？感觉没必要啊
已经有3人回复
-
FileCode能看出啥？
已经有15人回复
-
filecode
已经有8人回复
-
确定了，国自然21号放榜
已经有7人回复
-
综述论文作为代表作会不会影响评审专家的印象分？
已经有11人回复
-
关于代码变化问题，想知道的进来
已经有24人回复
-
静等基金结果
已经有16人回复
2楼2007-06-20 22:01:41
100