1/2 March 2023
Wholesale distributors must have suitable and adequate premises and storage facilities, to ensure proper storage and distribution of medicinal products.
Deficiencies in this area regularly come up in GPD Non-Compliance Report. For example, on 28 July 2022, the competent authority of Czechia (State Institute for Drug Control) has entered a report into the EudraGMDP database. It states that the company in question does not provide approved storage facilities. (Source: EudraGMDP Database, Inspection Date: 03. November 2021; Report Number: sukls279009/2021)*.
Against this background, the question arises as to what are actually the concrete requirements for premises and storage facilities according to the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01)?
Taking a look at Chapter 3 (premises and equipment), one finds mainly the following stipulations:
* 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.