GDP Non-Compliance Report documents numerous Deviations at German Wholesaler

The Competent Authority of Germany (Regierungspraesidium Freiburg) has entered a new GDP non-compliance report into the EudraGMDP database. The report is dated 06 October 2023, but was not published until the end of November.

Numerous GDP violations were identified during an inspection of a wholesale distributor based in Baden-Württemberg. The list of deficiencies found is quite long and the deviations run through almost all chapters of the EU GDP Guidelines. It appears to be particularly problematic that medicinal products requiring special conditions were stored under uncontrolled conditions and the temperatures were obviously far outside the specification.

In particular, the authority lists deficiencies in the following areas:

  • Premises: Inadequate premises concerning the storage of cold chain/cool storage medicinal products.
  • Temperature monitoring: The temperature was not controlled and was widely out of the specfications.
  • Responsible person: The responsible person was not in charge of any of his responsibilities. A change of the responsible person has not been notified to the competent authority.
  • Qualification of suppliers: Inadequate verification/due diligence checks of suppliers and the scope of their wholesalers' authorisation before purchase, no approval of supplier by the responsible person.
  • Falsified medicinal products: No adequate check of medicinal products concerning the security measures, no adequate checks for falsification. Safety informations given by the securpharm system were ignored.
  • Documentation: Purchases and sales were not documented adequately, neither in amount nor in batch documentation. Seamless tracing of all activities was not secured.

According to the report, the authority is planning a prompt re-inspection.

Source: EudraGMDP Database (Inspection Date: 29 September 2023; Report Number: 01). *

* 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.

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