GDP Non-Compliance Report due to GDP Violations concerning RP, Supplier Qualification, Operations and Trading

Recommendation

13/14 December 2022

The GDP Audit - Live Online Training
How to conduct and pass GDP Audits and Inspections

The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 18 January 2022 into the EudraGMDP database.

On 12 January 2022, the authority inspected a company located in North Rhine-Westphalia, Germany. During that inspection, it came to light that the company does not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC.

In the report, the authority lists the following four deficiencies:

• "no responsible person who possesses the required expert knowledge
•  the wholesaler is unable to guarantee that the regulations governing proper operations are being observed
• missing qualification of suppliers and customers
• trading of medicinal products which are not included in wholesale authorisation"

As a consequence, the wholesale authorisation was suspended.

Source: EudraGMDP Database (Inspection Date: 12 January 2022; Report Number: 24.05.17-07-0030) *

* 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.