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:
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.