The European Commission has published the final EU Guidelines for GMP (Complaints, Quality Defects and Product Recalls). “Extensive changes have been made to this Chapter which now reflect that Quality Risk Management principles should be applied when investigating quality defects or complaints and when making decisions in relation to product recalls or other risk-mitigating actions. It emphasizes the need for the cause(s) of quality defects or complaints to be investigated and determined, and that appropriate preventative actions are put in place to guard against a recurrence of the issue and clarifies expectations and responsibilities in relation to the reporting of quality defects to the Competent Authorities.” This is in line with Chapter 1 revision and addresses that effectiveness of CAPAs should be monitored and assessed. The guideline addresses both clinical and commercial drug product complaints.
Although the guideline is only 6 pages long, it is specific in terms of what should be captured during a quality defect investigation and focuses on addressing root cause, corrective and preventive action and monitoring of the effectiveness of those actions. The section on Recall is similar to what has been published by FDA. However, the guideline includes the recall of clinical investigational drugs.
Read the guidelines here.