Good Distribution Practices Auditing

Service summary

An assessment of controls protecting medical product quality through defined storage and distribution activities. The audit examines qualification, environmental control and the traceability of products and supply relationships.

Findings support distribution oversight and supplier decisions. The service does not grant a pharmaceutical distribution licence or replace official inspection, product release or the responsibilities of authorised supply chain parties.

Key objectives

• Assess medical product distribution controls
• Examine qualification and traceability
• Evaluate temperature and security arrangements
• Review returns and recall-related evidence

Methodology

Selected medical products and distribution events are followed through qualification, storage, transport and exception-management records.

• Agree products, distribution activities, applicable GDP criteria and boundaries.
• Review licences, responsibilities and quality management arrangements.
• Select suppliers, customers, consignments and exception cases.
• Observe storage, handling, security and environmental controls.
• Trace distribution records, temperature evidence and product identity.
• Assess returns, suspected falsification, complaints and recall interfaces.
• Report GDP findings and the limitations of the assessed scope.

Key outcomes

References: [G04] · [G14]

• GDP assessment report
• Qualification and traceability findings
• Condition-control evidence
• Returns and recall interface gaps