EMA revises Process Validation Guideline

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.