EU GMP Chapter 9 - Self Inspection

What it says

Manufacturers must conduct self-inspections, covering personnel, premises, equipment, documentation, production, quality control, distribution and complaint handling, to monitor GMP compliance and propose corrective measures, following a pre-arranged program with a written record of conclusions and corrective actions.

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

What it means in practice

• A self-inspection program is the manufacturer's own internal audit function, and its credibility depends on whether findings genuinely lead to corrective action rather than being recorded and left unaddressed.
• Self-inspection findings are frequently compared against findings from external regulatory inspections, since a mature self-inspection program should be catching many of the same gaps an external inspector would find.
• The requirement for a written record of conclusions and corrective actions means self-inspection cannot be a purely verbal or informal walkthrough, it must produce documented, trackable output.

What inspectors look for

• Whether a pre-arranged self-inspection program exists and is actually being followed on schedule, rather than performed reactively or skipped.
• Whether self-inspection findings are tracked through to closure with documented corrective actions, similar to how deviations or CAPAs are managed.
• Whether the scope of self-inspections genuinely covers all the required areas, personnel, premises, documentation, production, quality control, distribution and complaints, rather than focusing narrowly on production alone.

Related regulations