EU GMP Chapter 8 - Complaints, Quality Defects and Product Recalls

What it says

Complaints, quality defects and product recalls must be managed under a single integrated system with a designated person responsible for managing complaints and quality defects, defined criteria for classifying a complaint as a formal quality defect, and documented recall procedures capable of being activated at any time.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Chapter 8 treats complaints, quality defects and recalls as one connected system rather than three separate programmes, which differs from the more fragmented way these can be organised under the equivalent US framework.
• A designated, named individual responsible for the complaint and quality defect system is an explicit organisational requirement, not just a described set of procedures.
• Recall procedures must be genuinely ready for activation at any time, which is typically verified through periodic mock recall exercises testing the system under simulated conditions.

What inspectors look for

• Whether mock recall exercises are actually performed periodically and demonstrate the system can identify and trace affected product within an appropriate timeframe.
• Whether the criteria for escalating a complaint into a formal quality defect investigation are documented and consistently applied.
• Whether the designated responsible person for complaints and quality defects has genuine authority and visibility across the relevant systems, not just a title.

Related regulations