Checklist for Implementation of GDP Principles - Part 1: Quality System

Recommendation

13/14 December 2023

The GDP Audit - Live Online Training
How to conduct and pass GDP Audits and Inspections

According to Chapter 1 (Quality Management) of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01), "wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities."

The organisation’s management is responsible for the quality system, which requires their leadership and active participation supported by staff commitment. The Responsible Person (RP) is to ensure that a quality management system is implemented and maintained. The management is to ensure that all parts of the quality system are documented, defined and are adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.

The quality system should also define the organisation’s change control process, the management of their outsourced activities and the formal process for reviewing the quality management system. All significant changes should be justified, validated and approved by relevant stakeholders via change control and risk management processes, using appropriate corrective actions and preventive actions (CAPA).

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 1 of the 2013 guidelines:

• Quality manual or equivalent documentation approach established
• Organisational structure of the distributor is defined in an organisational chart. The responsibility, role and interrelationships of all personnel is clearly indicated
• A Responsible Person (RP) is appointed by the management
• The RP has a written document clearly specifying their authority and responsibility for ensuring the quality system is implemented and maintained
• Change control system in place for changes to critical processes
• Change control and quality management encompasses the principles of quality risk management
• Management responsibilities are clearly defined with the quality system
• The quality system standard operating procedures (SOPs) ensure product is delivered to the correct recipient within agreed and satisfactory time periods
• Appropriate corrective and preventive actions (CAPA) are taken to correct deviations and prevent them
• System for management review in place

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.