17/18 April 2024
New GDP Non-Compliance Reports have been published in the EudraGMDP database, leading to a suspension of the WDA (wholesale distribution authorisation) of the inspected companies.
It is interesting to see what might lead to a suspension:
No distribution activities are performed: A Czech company lost its WDA because the "company does not ensure the services of qualified person and the warehouse is not available".
Insufficient quality system: The WDA of a German wholesaler was suspended because the "quality system did not ensure that the products delivered maintain their quality and remain within the legal supply chain during storage and transportation, especially with regard to cold chain products". Furthermore the Responsible Person (RP) "did not fulfill his duties adequately" and "qualification of suppliers and customers was partly insufficient".
Possession of falsified medicines: Two U.K. wholesale distributers lost their WDAs (full and partial suspension) because they "did not detect or prevent falsified medicines re-entering into the legal supply chain". As result, inspectors found falsified medicines in the facility.
Source: EudraGMDP Database - and specifically: