WHO: Updates on Method Transfer
Recommendation

Thursday, 3 September 2026 9 .00 - 17.00 h
Establishment, Use and Maintenance of Analytical Reference Substances
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
17.08.2026FDA Warning Letter: Averaging Data to Override OOS Findings
12.08.2026ECA's Analytical Control Group Publishes Detailed Report on OOS Survey
12.08.2026BP Publishes Key Insights on Limits in Chromatographic Tests
04.08.2026BioPhorum Publishes a Roadmap for QC Sample Test Execution
04.08.2026USP AISQ Virtual Workshop: ECA AQCG Board Members Contributed as Speakers
04.08.2026Several FDA Warning Letters and Untitled Letters on Asbestos Testing of Talc in OTC Drug Products


