GDP Non-Compliance Report: No authorized Storage Facilities and Services of a Qualified Person not ensured
Recommendation
9 September 2025
Basel, Switzerland
Specifics in the Distribution of Medicinal Products
Register now for ECA's GMP Newsletter
After the competent authority of Czechia (State Institute for Drug Control) had just recently added four GDP Non-Compliance Reports to the EudraGMDP database, another one dated 26 April 2023 was added.
The new case is about a wholesaler located in Ostrava. From the knowledge gained during the latest inspection in March 2023, the authority came to the conclusion that the company has seriously violated the GDP regulations "by failing authorized storage facilites and the services of a qualified person are not ensured."
Source: EudraGMDP Database (Inspection Date: 14 March 2023; Report Number: sukls68453/2023). *
* 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
15.07.2025New Swissmedic Technical Interpretation on Returns of Medicinal Products
15.07.2025Two new GDP Non-Compliance Reports from Austria and Ireland published in the EudraGMDP database
15.07.2025Reminder: Participate in the GDP Implementation Survey until 31 July 2025
15.07.2025PDA Publishes Results of Transportation Validation Benchmarking Survey
10.06.2025Stimuli Article Proposes Revision of USP Definition of Controlled Room Temperature (CRT)
10.06.2025New MHRA Blog Post: Supplying Medicines to Ships, Aircraft and Oil Platforms