GDP Non-Compliance Report: Failure to Meet the GDP Principles of Cold Chain Products
![GDP in Switzerland (GDP 3)](files/eca/userImages/training.img/Z-GDP3-GDP-in-Switzerland-neues-Layout.jpg)
Recommendation
12 September 2024
Basel, Switzerland
Specifics in the Distribution of Medicinal Products (Course in english language!)
The competent authority of Portugal (National Authority of Medicines and Health Products, I.P.) has entered a new GPD Non-Compliance Report dated 24 May 2022 into the EudraGMDP database.
On 17 May 2022, the authority inspected a company located in Azambuja, Portugal . 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: "The wholesaler does not comply with the GDP principles of cold chain products, as the procedure in case of breakdown cold chamber wasn`t triggered." Further details on the nature of the violation are not provided by the authority.
As a consequence, the wholesale authorisation concerning cold chain products (requiring low temperature handling) was suspended.
Source: EudraGMDP Database (Inspection Date: 17 May 2022; Report Number: A015/09/H/006/2021/I02 NCR). * * 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.
Related GMP News
16.07.2024Templates for Shortage Prevention and Mitigation Plans issued by EMA
16.07.2024New Measures to Report Medicine Disappearances
16.07.2024GDP Non-Compliance Report for Czech Wholesale Distributor
16.07.2024Checklist for Implementation of GDP Principles - Part 9: Transportation
12.06.2024EU adopts Supply Chain Law - Implications for pharmaceutical Companies