GDP Non-Compliance Report: Numerous Major GDP Violations at Irish Wholesale Distributor

Recommendation

20 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1 only

The competent authority of Ireland (Health Products Regulatory Authority, HPRA) has added a new GDP Non-Compliance Report dated 02 November 2022 to the EudraGMDP database.

During an inspection of a wholesale distributor located in Donegal, which was conducted on 11 October 2022, a number of major deviations from Good Distribution Practice were found.

In the report, the authority only lists the most important findings. But even this list is very long:

• "Storage of medicinal products at an unauthorised premise.
• The responsible person failed to demonstrate control of activities occurring under the WDA and the accuracy or quality of GDP records.
• Procure and supply activities taking place at an unauthorised premise.
• There were no records pertaining to wholesaling activities, conducted under the WDA, at the wholesaling site.
• The quality management system at the site was not maintained or in use.
• The wholesaling premise was not secured and the area in which medicinal products were stored was not fit for purpose."

Thus, the deficiencies seem to extend across almost all chapters of the EU GDP Guidelines. As a result, this led to an immediate suspension of the authorisation.

Source: EudraGMDP Database (Inspection Date: 11 October 2022; Report Number: 32973). *

* 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.