ISPE Good Practice Guide: Technology Transfer, 2nd(2014)

lwjxz

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

胜利者

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胜利者

大侠，你的水印全在

Eleven

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fang211033

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小米0

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风行者

谢谢分享      

mxye2005

谢谢分享！

Tiger1986

好东西啊！！！楼主还有其他资料ISPE资料吗？

xqliu

学习一下啦，谢谢提供分享。

krishnayuto

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syhorchid

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Zucker

这么好的资料一定要顶，虽说要保护知识产权，但是我们实在是没有足够的资金去download，不多说了，万分感谢在心中。哥们威武。谢谢了。

zhou04

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dasheng1980

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beiwei5du

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潇湘子

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另外，里面的水印全在，出于保护自己，建议将里面的水印去掉再传，否则小心会有法律纠纷。   

jianhua5144

有没有第5和8卷呢，谢谢了

fanghygg

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懒虫9527

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