GDP Non-Compliance Report for Spanish Wholesale Distributor

Recommendation

13/14 December 2023

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The Spanish Agency Of Medicines And Medical Devices has added a new GDP Non-Compliance Report dated 31 August 2023 to the EudraGMDP database. During an inspection of a wholesale distributor located in Fuenlabrada, a series of deviations from Good Distribution Practice were found.

In the report, the authority addresses findings in the following areas:

• Quality management system: It was not guaranteed that the quality management system is applied and maintained.
• Records: Batch numbers were not documented, and the batch number does not appear on the supply delivery note.
• Deviations: Irregularities have not been adequately investigated and documented.
• Warehouse: Warehousing operations do not guarantee proper stock security.
• Supply chain security: The provisions on theft, loss and other diversion of medicines in the distribution process were not followed. It was not guaranteed that the supplied product remains within the legal supply chain during storage and transport. 

The authority writes that the following wholesale distribution activities are effected: "Procuring, holding, supplying and storage by contract of medicines for human use, with marketing authorization in the EEA country(ies), for psychotropic, narcotic, blood-derived, immunological, thermolabile, veterinary, immunosuppressive and cytostatic medicines."

The deviations found led to a suspension of the company's authorisation.

Source: EudraGMDP Database (Inspection Date: 27 July 2023; Report Number: IIBPD/FRG/20230811). *

* To find the respective report, please click on "Non-Compliance Reports" in the menu on the left-hand side and select in "From Date / To Date" the month the inspection took place. After clicking on "Search" the results list will be displayed, from which you can choose the report with the number mentioned above.