7 September 2022
During various ECA training courses, the question came up who actually issues a GDP certificate and which companies can obtain such a document. The question is easy to answer: In the EU, the national competent authorities are responsible for inspection of campanies located within their own territories. These national competent authorities have to issue the GDP certificate. However, there are some requirements for certification and not all companies can obtain a GDP certificate.
The details of the GDP inspection and certification are defined in the EMA/EU Commission document "Compilation of Community Procedures on Inspections and Exchange of Information" (EMA/572454/2014).
Wholesale distributors of medicinal products must possess an authorisation to engage in activity as a wholesaler in medicinal products. The national competent authority of the member state in which the wholesale distributor operates issues these authorisations.
The European Medicines Agency (EMA) summarises the procedure as follows: "A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority that carried out an inspection if the outcome of the inspection confirms that the wholesale distributor complies with Good Distribution Practice, as provided by European Union legislation. If the outcome of the inspection is that the wholesale Distributor does not comply a statement of non-compliance may be entered into EudraGMDP. GDP certificates and statements of non-compliance may be issued to wholesale distributors of medicinal products and distributors of active substances."
EudraGMDP is the name for the Union database referred to in article 111(6) of Directive 2001/83/EC and article 80(6) of Directive 2001/82/EC. It contains the following information:
Due to the restrictions caused by COVID-19, the period of validity of MIA’s, WDA’s, GMP and GDP certificates is automatically extended until the end of 2021.
The use of the EudraGMDP database is recommended as a secure source of information. From the main database home page, both GDP certificates and non-compliance reports can be accessed.
In the Supply Chain, many logistic activities are outsourced to service providers, e.g. logistic vendors. Transport companies do not need to hold a wholesale distribution authorisation to transport medicinal products. However, they should follow the parts of the GDP guideline relevant to their activities. Therefore transport companies need to follow GDP but will not receive a GDP certificate.
An independent assessment of compliance against international GDP requirements could be an effective way for logistic vendors to establish that their quality management systems align with the GDP requirement. ISO is an abbreviation for the International Organization for Standardization, an independent, non-governmental international organization. There are a variety of ISO standards that transport and logistic companies can implement. Achieving an ISO certification means implementing a management system that improves the processes and procedures. Before signing a contract, a standard question may be about the type of certificates the company holds. In this way, quality standards can help to gain a competitive advantage in the transport and logistics sector.
ISO 9001 is a generic quality management system providing a good framework for any organisation. However, the EU GDP expectations are not clearly detailed in this standard. It is therefore recommended that companies using the ISO framework incorporate the specific GDP requirements to ensure a compliant and workable QMS is available for the company.