EMA revises Guideline on Process Validation for Finished Products

The EMA (European Medicines Agency) has published the revised version of its “Guideline on process validation for finished products – information and data to be provided in regulatory submissions“ on 21 November 2016.

The amendment is considered to be minor and only comprises an update to the definition for “on-line measurement" included in the glossary. A consultation phase was considered to be unnecessary as the document is not intended as a full revision of the guideline.

Source:
EMA: Guideline on process validation for finished products