Revalidation

Repeating validation, in full or in part, after a change to a process, equipment, material or site, or at planned intervals, to show that the validated state still holds. How much is repeated depends on the risk of the change, so the scope is decided through change control and quality risk management. PIC/S Annex 15 states that significant changes to facilities, equipment and processes that may affect product quality should be validated, with the extent set by risk assessment. For products approved in Japan, revalidation data are often what the MAH needs before it can file a partial change application or a minor change notification.