ISPE 技术转移电子书，第二版，2014年。
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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
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