Two new GPD Non-Compliance Reports Published in June 2022

Recommendation

20 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1 only

In June 2022, two new GPD Non-Compliance Reports were entered into the EudraGMPD Database.

In both cases, it was found during an inspection that the companies concerned did not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC. As a consequence, the wholesale authorisations were suspended.

German Wholesale Distributor

The first GPD Non-Compliance Report, dated 01 June 2022, comes from the competent authority of German (Department of Occupational Health and Safety, Customer Protection and Health). During an inspection at a wholesale distributor from Cottbus, Brandenburg, the following deficiencies were found:

• No access to pharmaceutical Quality System
• No responsible person for Wholesale Distribution

Source: EudraGMDP Database (Inspection Date: 02 May 2022; Report Number: G3-5423/dubrau_roge_20220601) *

French Wholesale Distributor

On 16 June 2022, the competent authority of France (National Agency For The Safety Of Medicine And Health Products) entered a new GPD Non-Compliance Report. This report refers to an inspection performed at a wholesale distributor located in Tierce.

The authority lists the following deficiencies:

• Deficient quality system
• Unsecured and uncontrolled storage conditions (temperature) including for cold chain products
• Failure to implement serialization
• Non-compliance with public service obligations

Source: EudraGMDP Database (Inspection Date: 06 January 2022; Report Number: 2022_NCS_001) *

* 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.