The GDP Quality System: What to consider?

Deficiencies in the quality system repeatedly lead to so-called GPD Non-Compliance Reports.

Example: GDP Non-Compliance Report to an Austrian Wholesaler

For example, in February 2022, the competent authority of Austria, the Austrian Medicines and Medical Devices Agency (BASG - Bundesamt für Sicherheit im Gesundheitswesen), entered a report into the EudraGMDP database listing deficiencies regarding the quality system (e.g., handling of deviations) as a reason for withdrawing the Wholesale Distribution Authorisation (WDA).

Source: EudraGMDP Database (Inspection Date: 19 July 2021; Report Number: INS-482720-13742459) *

* 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.

Quality System Requirements

Against this background, the question arises as to what the actual requirements for the quality system in the GDP environment are and which processes must be in place within the company?

The key requirements for the structure and scope of the quality system are specified by the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01).

According to chapter 1.1, wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities. The quality system should be fully documented and its effectiveness monitored. The responsible person must ensure that the quality management system is implemented and maintained.

The key elements of a quality management system in the GDP environment include:

  • A quality manual or equivalent documentation approach;
  • A change control system that also takes into account quality risk management principles and is proportionate and effective;
  • Processes to ensure that records are made contemporaneously;
  • The control and review of outsourced activities;
  • A procedure for documenting deviations;
  • A CAPA-System (Corrective and Preventive Actions);
  • A formal process for reviewing the quality management system on a periodic basis (Management Review).

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