Self-inspections are essential tools to verify whether the wholesaler complies with its own quality system and the requirements imposed by GDP guidelines. They are the ideal means of checking whether the various aspects of the company's own quality system are effectively implemented and maintained.
To this end, the pharmaceutical wholesaler establishes self-inspection program specifying the frequency, methods, responsibilities and method of reporting. Such a plan takes into account the importance of the processes to be audited and the results of previous audits. Auditors must perform their duties objectively and without prejudice. Results are communicated to those involved and to management. Where non-conformities are found, an investigation into the possible causes must be carried out. Based on this analysis, the necessary actions for Correction And Prevention are then taken. CAPA's should be proportionate.
As proof of continuous quality improvement, the organization systematically documents the results of the findings, the nature and causes of non-conformities and the results of the Corrective And Preventive Actions taken.
Agenda
- Self-Inspections and audits
- Handling non-conformities
- CAPA establishment and management