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Wednesday, December 21, 2016

EMA revises Guideline on Process Validation for Finished Products

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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.
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