GDP Compliance in the Pharmaceutical Supply Chain: Authorisation vs. Certification

Good Distribution Practice (GDP) safeguards the quality, safety and efficacy of medicinal products during storage and transport. In the European Union, the legal framework is defined by the 2013 EU GDP Guidelines, which apply to wholesale distributors and cover quality systems, personnel, documentation, storage, transport and deviation management. Implementation and enforcement are handled by national authorities in each Member State.

A key distinction must be made between official wholesale distribution authorisations (WDA) and commercial GDP certifications. A WDA is granted by a competent authority following document review and on-site inspection. It is site- and activity-specific and subject to ongoing supervision. Operating without such authorisation is not permitted.

Commercial GDP certificates, by contrast, are voluntary and issued by private bodies. They may support supplier qualification and demonstrate quality standards, but they do not replace regulatory authorisations or customer audits. Responsibility for GDP compliance and service provider qualification always remains with the contracting pharmaceutical company.

27-02-2026