CAPA Follow-up

The audit process could identify observations related to the GMP compliance of the audited company. The audited company should pay attention to them, establishing an Action Plan for its resolution.

AFA sends an audit report (Audit Report Letter) to the audited company. In this report, the observations found are identified and the corrective actions are included (if they have been already received). Where appropriate, a GMP Audit Certificate is sent to the audited company.

From this point, AFA follow-up activities are described below:

  1. Action Plan request when sending the Audit Summary
  2. Evaluation of the Action Plan suitability
  3. Distribution of the Action Plan to the audit sponsors
  4. Follow-up of the Action Plan Implementation and evolution (at least semi-annual)
  5. Evaluation of the Action Plan Update suitability
  6. Distribution of the Action Plan Update to the sponsors
  7. When the recommended validity period expires, follow-up performance if the interest remains