Follow-Up GMP Audit

A follow-up GMP Audit is generally associated with a specific and critical nonconformity. When a nonconformity is detected, it is given to the manager of the activity being audited for corrective action.

Following the corrective action, a follow-up GMP Audit may be required to ensure the effectiveness of the corrective action. Follow-up GMP Audits are not necessary on all corrective actions, but should be performed on any that would be classified as a “critical & major”, or any that may involve a complicated corrective action. Follow-up GMP Audits may also be performed if an activity receives an excessive number of “minor” nonconformities. Follow-up GMP Audits are extremely limited in scope, and normally only involve the specific activity, or corrective action. Follow-up GMP Audits generally do not take the place of planned GMP Audits, and GMP Audit scheduling is normally determined at the time the corrective action is determined.