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

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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

454052002

有翻译版么？？？

路人萧郎

早就看，但是内容也没什么特别好的

王于顺

有翻译版吗？？