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