GDP Audits

Product quality built into manufacturing can be lost in distribution. A medicine that left the factory perfect can be rendered unusable — or unsafe — by a temperature excursion, a mix-up, or a break in traceability. PharmExpert's Good Distribution Practice audits verify that warehousing, transport and wholesale operations preserve the identity, integrity and traceability of medicines from release to point of dispense.

We audit distribution centers, cold-chain and ambient warehouses, third-party logistics providers, transport lanes and wholesale dealers against EU GDP Guidelines (2013/C 343/01), WHO GDP guidance and applicable national requirements. The assessment covers the distribution quality system, premises and temperature control, qualification of equipment and transport, handling of returns and recalls, falsified-medicine safeguards, and the role and effectiveness of the Responsible Person.

Cold chains receive particular scrutiny, because they are where the most common and most costly distribution deviations occur. We examine temperature mapping, continuous monitoring, alarm and excursion management, and — crucially — the qualification of shipping lanes under real-world conditions rather than on paper. A warehouse that maps perfectly while product cooks in transit is not in control, and our audits are designed to surface exactly that kind of gap.

Findings are risk-ranked and referenced to the applicable GDP framework, with clear remediation direction and optional CAPA follow-up. Whether you are qualifying a new logistics partner, expanding cold-chain distribution into new markets, or maintaining periodic oversight across a network, the audit gives you defensible assurance that your supply chain protects the product.