Sunday, 9 November 2014

WHO: Revision of its Process Validation Guideline

The World Health Organisation has published a second draft on the “Revision of its Process Validation Guideline”.

According to ECA, the table of contents and the scope have remained unchanged. Yet, the definition of process validation contains the life-cycle approach in the glossary already. Compared to the first draft, the new version now also explains the matrix approach or bracketing.

The main change is with the chapter "process qualification". Here it is stated that a risk assessment is required for the change in batch size from scale up to commercial batch size. Explicitly, manufacturers are requested to implement the new validation approach. However, it is mentioned that full implementation may take time. In the interim, the traditional approach or concurrent validation may be accepted. Also a hybrid approach (based on a scientific basis and risk management principles) may be an alternative.

For details see ECA

Posted by Tim Sandle