GDP news – Many so-called “GDP certificates” are issued. But what are the requirements?

With the publication of the new GDP Guideline in 2013 the legal requirements concerning the Good Distribution Practice increased throughout the complete legal distribution chain from manufacturing and release to distribution to the patient.

The competent supervisory authorities carry out GDP inspections of companies that undertake tasks requiring GDP in the course of distribution. Since the new GDP Guideline came in force, many companies which come into contact with the supply chain of medicinal products tries to receive a GDP certificate from the authorities in order to demonstrate GDP compliance to their customers.

Even though many of the actors in the supply chain are not under the Authorities supervision the GMP/GDP costumers expect they implement GDP nevertheless. BUT the competent authorities will not carry out GDP inspections at transport companies, shipping companies or at airport hubs. This applies for all European competent authorities.

This gap is now filled by a number of service providers that grant so-called “GDP certificates”. Some accredited and some non-accredited bodies have started to offer “GDP certificates” for shipping companies or even airports.
This is a huge misunderstanding, as these commercial “GDP certificates” cannot be compared to the official GDP certificates issued by competent, supervisory GDP authorities.

But many actors in the supply chain are not aware of this fact.

The so called “GDP certificate” might just be a marketing instrument, as it does not confirm GDP compliance within the meaning of an official GDP certificate issued only by the competent supervisory GDP authority.
What should companies do when not inspected by the authorities?

It is important that each of these companies implements the relevant GDP requirements which can be done by GAP analysis of the GDP Guideline.
The company can establish an internal quality management system applying the GDP requirements and have sufficiently qualified personnel.

No GDP certificate is required for transportation of medicinal products.