Checklist for Implementation of GDP Principles - Part 8: Self-Inspections

According to Chapter 8 (Self-Inspections) of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01) "self-inspections should be conducted in order to monitor implementation and compliance with GDP principles and to propose necessary corrective measures."

The RP is responsible to ensure this program is maintained and thus is responsible for keeping up to date with changes in legislation and regulations impacting the business with regards to GDP. Other departments may support the RP by performing local audits and/or participating in the organisation’s self-inspection program.

Checklist: Implementation of GDP Principles at Wholesale Distributors

The following checklist provides a generic overview and could be used as a minimum requirement related to Chapter 8 of the 2013 guidelines:

• A self-inspection programme is implemented to cover all aspects of GDP and compliance within a defined time frame
• Self-inspections are conducted in an independent and detailed manner (by designated competent person(s) from the company and independent external experts)
• Subcontracted activities are a part of the self inspection programme
• Reports contain all observations
• A copy of the report is submitted to the organisation’s management and other relevant personnel
• Causes of irregularities and/or deficiencies are determined and the CAPA is documented and followed-up

Reference

The points listed above are an excerpt from the "ECA Roadmap to Good Distribution Practice (GDP)", which includes checklists to verify the minimum implementation of GDP, based on the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01). The European GDP Association (GDPA) has compiled this document to support pharmaceutical and wholesaler businesses in implementing regulatory requirements and expectations in their quality systems. The PDF is available for download free of charge in the GDPA members' area.