13/14 December 2023
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).
The following checklist provides a generic overview and could be used as a minimum requirement related to Chapter 1 of the 2013 guidelines:
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.