EU GMP Annex 11 Draft Strengthens Audit Trail Requirements

The draft revision of EU GMP Guideline Annex 11 provides expanded requirements for audit trails, ensuring changes, deletions, and eventually data creation are traceable. Industry experts and inspectorates have addressed key questions on the topic.

For batch release, audit trail reviews must be governed by an SOP, carried out by individuals independent of the related process, and documented as part of the batch record review. Any discrepancies must be investigated, escalated where necessary, and assessed by the Qualified Person (QP) before product release.

During inspections, failure to provide a justification for data changes or deletions can be considered a deficiency, as Annex 11 requires reasons to be documented. If the system lacks functionality to capture justifications, firms must apply workarounds such as logbooks and detailed SOPs.

These clarifications emphasize the regulatory expectation for robust data integrity controls in pharmaceutical manufacturing.

05-09-2025