| 查看: 6317 | 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
WoS一区Frontiers in Genome Editing基因编辑方法与应用方向专题邀稿（影响因子4.9）
已经有0人回复
-
WoS一区Frontiers in Genome Editing基因编辑方法与应用方向专题邀稿（影响因子4.9）
已经有0人回复
-
药理学论文润色/翻译怎么收费?
已经有63人回复
-
WoS一区Frontiers in Genome Editing基因编辑方法与应用方向专题邀稿（影响因子4.9）
已经有0人回复
-
求购时间长一些的硝酸钍
已经有0人回复
-
跪求一支AAV293细胞
已经有1人回复
-
广西医科大学基础医学院自身免疫病课题组招收基础医学、药学和生物学等专业的研究生
已经有7人回复
-
[学习资料分享] FAERS数据库的不良反应挖掘(频数法/贝叶斯法)
已经有1人回复
-
招收医学、基础医学类调剂研究生
已经有0人回复
-
是否属于脾肾阳虚证
已经有0人回复
-
广西医科大学基础医学院自身免疫病课题组招收基础医学相关专业的调剂研究生
已经有2人回复
63楼2015-12-01 21:18:52
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！
