New GDP Non-Compliance Reports

Recommendation

6/7 November 2024

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Temperature controlled Transports of Medicinal Products

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.

Reasons for a suspension

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:

• Report Number : sukls132322/2019
• Report Number : DE GAALG 41403/053
• Report Number : UK WDA(H) 18799 Insp GDP 18799/303632-0035 NCR
• Report Number: UK WDA(H) 39307 Insp GDP 39307/303632-0036 NCR