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WHO Updates Technology Transfer Guidelines for Pharma
The WHO has updated its technology transfer guidelines in the 2022 Technical Report Series 1044 (TRS 1044 - Annex 4), replacing the 2011 version.
The new annex outlines key aspects of pharmaceutical technology transfer, covering quality management, premises, equipment, validation, and documentation. A major addition is Chapter 12, detailing the phases of a technology transfer project, including:
- Project initiation, planning, execution, and close-out
- Production (finished pharmaceutical product)
- Analytical procedure transfer in quality control
- Cleaning validation
Additionally, Appendix 1 provides documentation requirements for technology transfer, focusing on method transfer in analytical procedures.
The updated WHO guidelines emphasize risk-based quality management, validation, and a life-cycle approach to ensure effective technology transfer. The full document is available on the WHO website.
22-03-2025