EMA revises Process Validation Guideline
Recommendation
28-30 April 2026
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The News "Detailed analysis of EMA's new Guideline on Process Validation" from March 2014 reported about EMA's revised process validation guideline entitled "Guideline on process validation for finished products - information and data to be provided in regulatory submissions". Now, the European Medicines Agency has surprinsingly published a new revision.
Why this revision? What has changed?
Beforehand, please note that the changes are marginal and characterised as "minor update" by the EMA. Solely the definition for "on-line measurement" has been incorporated into the glossary. For the EMA, this is not a complete revision and thus there will be no consultation phase.
For further details please refer to the "Guideline on process validation for finished products - information and data to be provided in regulatory submissions" issued on 21 November.
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