WHO: Draft of GMP-Validation, Appendix 7

WHO: Draft of GMP-Validation, Appendix 7

The WHO has published a proposal for revision of the Supplementary Guidelines on GMP: Validation, Appendix 7: Non-sterile Process Validation in April 2013. The revised document is expected for October 2013, after its presentation to the WHO Expert Committee on Specifications for Pharmaceutical Preparations.

 

Further to the “Supplementary Guideline on Good Manufacturing Practices: Validation”, as published in the WHO Technical Report 937, additional guidelines to assist current approaches in GMP are published to support the scope of process validation linked to quality risk management and quality by design principles as described by WHO and ICH.

This draft guideline allows for different approaches in process validation and describes the principles applicable to non-sterile finished pharmaceutical dosage forms with the focus on the life-cycle approach. The life-cycle approach links product and process development, validation of the commercial manufacturing process and process maintenance during routine commercial production. A risk based approach to validation is recommended to ensure that a process is in a state of control.

If you are interested in more details or would like more information on how to comment on the proposal, please find the 15-pages draft guideline here.