Glossary
Revalidation
Reconfirming, following a change or the outcome of a periodic review, that a process, equipment, or system remains in a validated state.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
-
The risk assessment QRM/EU2/061/2025 did not evaluate the need for revalidation of the Meropenem API manufacturing process following the installation of new RABS and modification of the filling line layout.
EMA · EU GMP NCR (EudraGMDP) · 2026-03-27 -
Modifying the potency test method to obtain passing potency results without scientific justification and revalidation, and without assessing the impact of these changes on the accuracy of the potency results for all previously distributed batches within expiry; b.
FDA · FDA Warning Letter · 2024-10-22 -
Failure to sign and date equipment validation/revalidation records.
FDA · FDA 483 · 2024-01-17
