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ECA/PQG Guides

Cover of the Good Distribution Practice for Active Substances Guidance Cover if the GDP Guidance on Interpretation and Implementation

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Good Distribution Practice Audits

Since September 8, 2013 all stakeholders in the supply chain of medicinal products need to comply with Good Distribution Practices as laid down in the European Guideline.

Manufacturers of medicinal products have to make sure that the products will be distributed under controlled conditions. Therefore, wholesalers, transport companies, warehouses and other partners in the supply chain will have to be selected carefully. An ongoing supervision of these organisations is necessary. It is the aim of the GDP Group to provide a standardized scheme to audit GDP compliance at all levels of the supply chain.

1. GDP Self Assessment

Wholesalers, transport companies, and warehouses may contact us for a self assessment audit. Depending on the size of the organization and their facility we perform a 1 to 4 day audit.

2. GDP Compliance Audits

GMP Compliance Audits can only be performed on behalf of a manufacturer of medicinal products. We offer to audit all organisations involved in the distribution channel. Audits my last between 1 and 4 days and will be performed by experienced GDP Auditors. Contact us for more information.