Insufficient Quality System leads to GDP Non-Compliance Report

Recommendation

14/15 December 2021

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Chapter 1 of the EU GDP-Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use) requires a Quality System. In general, the Quality System should have written procedures e.g. in the Quality Manual and in SOPs, about how each requirement of the EU GDP-Guidelines will be implemented in the company.

Thus, wholesalers must ensure that their Quality Management Systems (QMS) is aligned with the GDP requirement. Otherwise, this can lead to a GDP Non-Compliance Report, as a recent example shows.

The competent authority of Romania (National Agency for Medicines and Medical Devices of Romania) has entered a new GPD Non-Compliance Report dated 22 January 2021 into the EudraGMDP database.

During an inspection conducted in November 2020, it came out that the company does not comply with the GDP principles on several aspects. The Romanian authority lists the following failures:

• No change control system has been implemented.
• Deviations were not documented.
• No self-inspections were performed.
• Information on staff training could not be provided.

As a consequence, the wholesale permission was suspended.

Based on the information gained during the inspection, the company only supplied medicines to Romanian customers. According to the authority, there is no need to recall the medicines distributed by this wholesaler.

Source: EudraGMDP Database (Report Number: NCD/010/RO)