Commercial GDP Certificates: Helpful Tool or Questionable Assurance?

In the pharmaceutical supply chain, many logistical activities are outsourced to specialized service providers, including transport companies. These providers, who are solely responsible for the physical distribution of medicinal products, are not directly supervised by regulatory authorities and therefore do not receive an official GDP certificate (Wholesale Distribution Authorisation, WDA). Nevertheless, they are obliged to comply with the requirements of the EU GDP Guidelines to safeguard product quality and patient safety.

For logistics service providers, external GDP certification can be an attractive way of demonstrating compliance. Commercial GDP certificates promise standardized quality assurance and can support the qualification of logistics partners. At the same time, they raise important questions about their practical value and reliability.

Key Challenges and Considerations

Commercial certificates may serve as evidence of adherence to GDP standards, but not all are issued under accredited schemes. This lack of standardization makes it difficult to distinguish trustworthy providers from less reliable ones. Moreover, certificates alone rarely replace the need for thorough audits and robust quality agreements.

When such certificates are used in the qualification of a service provider, several points should always be kept in mind:

• Certificates generally do not replace an audit.
• Certification bodies are not necessarily independent.
• The true performance of a logistics provider only becomes visible once operations have begun.
• Continuous monitoring based on measurable KPIs/QPIs is strongly recommended.

Conclusion

For logistics providers, external GDP certification can be useful to demonstrate compliance with GDP requirements. However, commercial certificates should be read critically and always be complemented by additional qualification measures. In practice, audits, quality agreements, and performance monitoring remain indispensable to ensure that the integrity of medicinal products is safeguarded throughout the supply chain.

Webinar

These aspects will also be addressed in more detail during the ECA GDP Webinar “Commercial GDP Certificates” on Monday, 3 November 2025 (14.00–16.00 h CET). Dr. Torsten Schmidt-Bader will provide a practical and comprehensive overview of GDP certification in practice, highlighting key challenges and considerations for both logistics partners and pharmaceutical companies.