Guideline on Process Validation (EMA)

This guideline replaces the previous guideline on process validation.The guideline is brought into line with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Q8, Q9 and Q10 documents. The possibility to use continuous process verification in addition to, or instead of, traditional process verification described in the previous guideline has been added.

The draft EMA Guideline on Process Validation, is currently open for comment. Members of the ISPE were consultated and being asked to provide comments.

Download the draft guideline.