WHO: Updates on Method Transfer
Recommendation

Thursday, 29 October 2026 9 .00 - 14.00 h
Practical Approaches for Assessing the Risks of Impurities
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.
Related GMP News
21.10.2026EMA Updates Information Page on Bioequivalence Guidelines
21.10.2026BP Publishes new Draft Texts
21.10.2026FDA Identifies Critical Deficiencies in Analytical Testing and CGMP Oversight
07.10.2026Analytical Quality Group Developments May through August 2026
07.10.2026Two New FDA Warning Letters Put OOS Investigations in Focus
07.10.2026Pharmeuropa: Revision Proposed for Chapter 2.5.32 on Coulometric Karl Fischer Water Determination


