Expert Guidance on Risk-Based Audit Trail Reviews in EU GMP Annex 11

The new draft of EU GMP Annex 11 provides detailed requirements for audit trails, ensuring that creation, changes, and deletions of data are properly tracked. An expert panel from the pharmaceutical industry and inspectorates addressed questions on implementing these requirements.

Regarding risk-based audit trail review intervals and scope (Question 12), regulations do not mandate a specific procedure. Experts recommend applying ICH Q9 (2023), which offers various risk assessment methods, with FMEA (Failure Mode and Effects Analysis) being most commonly used in the industry. Typical numerical scales are 0–10, 0–5, or 0–6, with median values avoided for medium risk.

When defining review intervals, all batches should initially undergo full checks, with the possibility of reducing frequency over time (e.g., after one year). However, inspectors may raise objections if intervals are deemed insufficiently justified.

The expert team includes industry and regulatory representatives from Merck, Roche, Kereon, PharmAdvantageIT, and German inspectorates, providing authoritative guidance on audit trail compliance.

06-10-2025