WHO: Updates on Method Transfer
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In 2022, the WHO published the "Technical Report Series 1044, 2022" called "TRS 1044 - Annex 4: WHO guidelines on technology transfer in pharmaceutical manufacturing" on the subject of technology transfer. The previous document dates back to 2011 and has now been updated.
The new annex consists of the following chapters and subsections and also lists an appendix 1:
Background
Abbreviations
1. Introduction
2. Scope
3. Glossary
4. Due diligence and gap analysis
5. Organization and management
6. Quality management and quality risk management
7. Documentation
8. Premises
9. Equipment and instruments
10. Qualification and validation
11. Life cycle approach
12. Phases of a technology transfer project
Phase I: Project initiation
Phase II: Project planning
Phase III: Project transfer execution
Production (example: finished pharmaceutical product)
Quality control: analytical procedure transfer
Cleaning
Phase IV: Project review and close-out
References
Appendix 1 Documentation commonly required for technology transfer
Chapter 12 "Phases of a technology transfer project" under "Quality control: analytical procedure transfer" and Appendix 1 deal specifically with the topic of method transfer.
Annex 4 "TRS 1044 - Annex 4: WHO guidelines on technology transfer in pharmaceutical manufacturing" is available on the WHO website.
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