GDP certification by accredited bodies and GDP audit by QPs - dangerous misunderstandings

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Tuesday, 30 April 2024 9 .30 - 16.45 h

Pharma Supply Chain - GDP Requirements and Certification for Logistics Vendors - Live Online Training

With the publication of the new GDP Guideline in the year 2013 the legal requirements concerning the Good Distribution Practice have increased significantly. This has manifold consequences because now compliance with the quality requirements is controlled throughout the complete distribution chain until the final release to the patient. This is the objective at least.

The competent supervisory authorities carry out GDP inspections of companies that undertake tasks requiring GDP in the course of distribution. And this is where the problem already starts. Since the date of availability of the new GDP Guideline each company which comes into contact with the supply chain of medicinal products tries to receive a GDP certificate. After all, it is the declared objective of the EU to guarantee GDP compliance throughout the complete supply chain. The GDP certificates are listed throughout Europe in a central database called EudraGMDP. Here, the GDP non-compliance reports are also recorded. So what could be more natural than to attempt to be listed there in order to demonstrate GMP compliance to the customers?

But the EU GDP Guide defines the group of companies which are subject to supervision very strict. This means that many of the actors in the supply chain are not under supervision but must implement GDP nevertheless. The competent authority for GDP will normally not carry out GDP inspections at transport companies (shipping companies) or at airport hubs.

This gap is now filled by a number of service providers that grant GDP certificates. Some accredited or non accredited bodies have started to offer GDP certificates for shipping companies or even airports. An auditor of the (accredited) body carries out an audit and at the end a GDP certificate beckons which will then be advertised in the internet and in company brochures. And here a big misunderstanding arises. Because these commercial certificates cannot be compared to the GDP certificates issued by the supervisory authority. But many actors in the supply chain are not aware of this fact. The GDP certificate might be a marketing instrument such as the ISO 9001 certificate or a certificate certifying compliance with environmental standards. But it does not confirm GDP compliance within the meaning of an official GDP certificate. This can only be done by the competent supervisory authority.

One also hears more and more about so-called QP audits carried out by independent consultants who allegedly confirm GDP compliance by means of a GDP Certificate. As QPs play a central role in the pharmaceutical law it is assumed by some companies that these "QP certificates" have a particularly high significance and that they could virtually serve as substitute for the GDP certificate of the supervisory authority. But this is not the case - as has already been explained for the GDP certificates issued by accredited companies. A QP who actually works as part of the supplier qualification for a pharmaceutical company will never issue a GDP certificate or written confirmation.

What should companies do that would like to have a GDP certificate but will not be inspected by the authority? It is important that each of these companies implements GDP. The requirements can be checked in the GDP Guideline. A further certificate is not required. The key is an internal quality management system for establishing GDP requirements with sufficiently qualified personnel. In the case of a new customer/supplier relationship, for instance, the external auditor will want to see the concrete implementation of GDP - regardless of a GDP certificate of any organisation.