Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.
FDA anticipates that general validation protocols will cover responsibilities for conducting and approving validation studies, acceptance criteria, and revalidation schedules. FDA mandates firms to perform validation studies according to specified guidelines and document the results.