| 查看: 6330 | 回复: 146 | ||
| 当前只显示满足指定条件的回帖，点击这里查看本话题的所有回帖 | ||
[资源]
ISPE Good Practice Guide: Technology Transfer, 2nd(2014)
|
||
|
ISPE 技术转移电子书，第二版，2014年。 官网价格500 dollar。 Table of Contents 1 Introduction.......................................................................................................................... 7 1.1 Background and Purpose......................................................................................................7 1.2 Rationale for this Second Edition...........................................................................................8 1.3 Scope..................................................................................................................................9 1.4 Key Terms......................................................................................................................... 11 1.5 Technology Transfer in Relation to Drug Shortages.............................................................. 13 2 Technology Transfer Planning and Success Criteria..................................................... ....... ....15 2.1 Introduction.......................................................................................................................15 2.2 Technology Transfer Planning..............................................................................................15 2.3 Technology Transfer Success Criteria....................................................................................18 3 Technology Transfer Project Phases...................................................................................... 21 3.1 Form Transfer Team and Develop Charter............................................................................ 21 3.2 Consolidate Knowledge for Transfer and Develop Technology Transfer Proposal..................... 24 3.3 Identify Risks, Conduct Risk Assessments, and Develop Technology Transfer Plan................... 26 3.4 Technology Transfer Execution..............................................................................................32 3.5 Process (Procedure) Qualification...........................................................................................34 3.6 Finalize Transfer and Perform Review.....................................................................................35 4 Transfer of Knowledge for Analytical Procedures....................................................................... 39 4.1 Introduction..........................................................................................................................39 4.2 Overview of Transfer Process.................................................................................................39 5 Drug Substance Technology Transfer........................................................................................ 45 5.1 Introduction..........................................................................................................................45 5.2 Technology Transfer Process..................................................................................................45 6 Drug Product Technology Transfer............................................................................................ 51 6.1 Introduction..........................................................................................................................51 6.2 Technology Transfer Process..................................................................................................51 7 Appendix 1 – Quality Target Product Profile Example for a Film Coated Tablet............................. 53 8 Appendix 2 – Quality Target Product Profile Example for a Sterile Product................................... 55 9 Appendix 3 – Example Technical Risk Assessment (C&E Matrix).................................................. 59 10 Appendix 4 – Example Fishbone Analysis................................................................................. 63 11 Appendix 5 – Example of a Failure Mode and Effect Analysis (FMEA).......................................... 65 12 Appendix 6 – Example of Information that may be included in Technology Transfer Report..........................................................................................................67 13 Appendix 7 – References......................................................................................................... 73 14 Appendix 8 – Glossary............................................................................................................. 75 14.1 Acronyms and Abbreviations..................................................................................................76 14.2 Definitions......................................................................................................77  ispe.jpg |
回复此楼» 本帖附件资源列表
-
欢迎监督和反馈：小木虫仅提供交流平台，不对该内容负责。
本内容由用户自主发布，如果其内容涉及到知识产权问题，其责任在于用户本人，如对版权有异议，请联系邮箱：xiaomuchong@tal.com - 附件 1 : ISPE_GPG=_Technology_Transfer_(2nd_Ed)(2014).pdf
2015-06-19 12:36:39, 5.71 M
» 本帖已获得的红花（最新10朵）
ytjgouu» 猜你喜欢
见刊快的中文核心期刊
已经有2人回复
-
一志愿天中医中药学专硕，希望有b区的老师可以考虑一下我
已经有1人回复
-
药物学论文润色/翻译怎么收费?
已经有228人回复
-
调剂
已经有3人回复
-
药学学硕326求调剂
已经有0人回复
-
26年博士申请
已经有20人回复
-
求助 苯磷硫胺JP
已经有0人回复
-
100金币 阿莫西林克拉维酸钾片BP药典中提到的克拉维酸聚合物具体结构式是啥？
已经有2人回复
-
膳食补充剂合规性交流
已经有0人回复
-
一志愿浙大药学求调剂
已经有0人回复
-
高温高压反应求助
已经有4人回复
109楼2018-02-01 20:39:24
简单回复
sjshvdc2楼
2015-06-19 12:54
回复
五星好评 顶一下，感谢分享！
2015-06-19 13:24
回复
五星好评 顶一下，感谢分享！
2015-06-19 13:31
回复
五星好评 顶一下，感谢分享！
wangzgsh5楼
2015-06-19 13:56
回复
五星好评 顶一下，感谢分享！
liqide6楼
2015-06-19 15:41
回复
五星好评 顶一下，感谢分享！
2015-06-19 16:48
回复
五星好评 顶一下，感谢分享！
yyt_998楼
2015-06-19 17:57
回复
五星好评 顶一下，感谢分享！
work0379楼
2015-06-19 18:26
回复
五星好评 顶一下，感谢分享！
凝水石10楼
2015-06-19 18:40
回复
五星好评 顶一下，感谢分享！
wanlingyun11楼
2015-06-19 18:42
回复
五星好评 顶一下，感谢分享！
轻舞飞扬199012楼
2015-06-20 01:41
回复
五星好评 顶一下，感谢分享！
yyangpp13楼
2015-06-20 07:23
回复
五星好评 顶一下，感谢分享！
lieying1814楼
2015-06-20 12:53
回复
五星好评 顶一下，感谢分享！
5