EMA revises Guideline on Process Validation for Finished Products

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

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