Auditing / Self Inspections

 

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.

We offer:

  • Full external independent audits of your business.
  • Advice and guidance for existing / new internal auditors.
  • Assistance in creating audit procedures and plans.

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