Audits and self-inspections are an integral part of any Quality Management System.
The regulations state that an internal self-inspection program should be implemented covering all GDP activities within the business.
In addition, audits of external suppliers/subcontractors are required.
The scope of any self-inspection or audit should be:
- To assess compliance with EU Guidelines on Good Distribution Practice
- To assess compliance with the company Quality Management System
The Responsible Person is required to carry out at least one full self-inspection annually.
Reports of all audits and self-inspections should be documented along with any observations. Corrective action should be agreed and followed up using a CAPA system (Corrective And Preventive Actions)
Self-inspections carried out by external impartial companies are also deemed to be useful.
- Full external independent audits of your business.
- Advice and guidance for existing / new internal auditors.
- Assistance in creating audit procedures and plans.