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.