EU GDP Audit Compliance Checklist

This EU Good Distribution Practice audit checklist helps wholesalers and distributors of medicinal products assess and document compliance. It covers quality systems and management review, personnel roles and training, premises hygiene, environmental controls and temperature mapping, equipment maintenance and calibration, computer system security and backups, documentation and SOP lifecycle, and transaction records. Operational controls include supplier and customer qualification, receipt and storage (including FEFO), segregation and destruction of obsolete stock, picking and packing, complaints, returns and recalls, and safeguards against falsified medicines. Transportation requirements address validated temperature control, seasonal configurations, hub use, deviations, delivery protocols, and container, packaging, and labelling requirements.