GDP Non-Compliance Report: No GDP conform Quality System

The competent authority of Germany (Thuringian State Authority for Consumer Protection / Thüringer Landesamt für Verbraucherschutz) has entered a new GPD Non-Compliance Report dated 21 July 2022 into the EudraGMDP database.

Several GDP deficiencies were identified at a company registered in Magdala, Thuringia, which in consequence led to the suspension of the wholesale distribution authorisation (WDA). Among other things, the authority criticized the lack of a GDP-compliant quality system.

According to Chapter 1.1 of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01), wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities. Further details on the structure of the quality system can be found in chapter 1.2 of the EU GDP Guidelines.

In addition, the report lists two other deficiencies:

  • The responsible person (RP) does not properly perform his or her duties;
  • The wholesaler is unable to guarantee that the regulations governing proper operations are being observed.

The authority further notes that the WDA is limited to the sale of disinfectants and medicinal gases and that the company's customers are only located in Germany.

Source: EudraGMDP Database (Inspection Date: 02 November 2021; Report Number: DE_TH_GDP/2021/008) *

* 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.

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