Complaint Handling and Recall Management - Live Online Training How to implement EU-GMP Chapter 8

During this Live Online Training, you will learn all relevant aspects to efficiently organise and improve your Complaint Handling and Recall System to fulfil current GMP requirements and to get the best benefit for your daily business.

In principle, every complaint might cause a recall, and every complaint may provide an opportunity to improve.

According to the EU-GMP Guide Chapter 8, the pharmaceutical industry must review all complaints and other information concerning potentially defective products carefully according to written procedures. In order to provide for all contingencies, a system should be designed to investigate the need to recall, if necessary, promptly and effectively products known or suspected to be adulterated from the market-place.

According to the EU- GMP Guide, a person should be designated responsible for handling the complaints and deciding the measures to be taken. The Qualified Person (QP) together with the Qualified Person for Pharmacovigilance (QPPV) should be made aware of any complaint, and be actively involved in the investigation and any subsequent recall.

The handling of technical complaints (also called non-medical complaints) triggers high demands on the process organisation and quality system. However, these complaints are also a chance for continuous improvement and to prevent the reoccurrence of future failures.

Reviewing FDA’s Warning Letters of the last fiscal years reveals that Complaint Handling processes are a hot topic. Recent media coverage of recalls due to non-GMP operations and counterfeit products entering the supply chain are also an indication of how important it is to treat all complaints with the highest priority. The main failures can be found in the overall process and in inadequate investigations, as the following excerpts show:

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