Is the audit trail review prior to the release of each batch a regulatory requirement or is it only recommended so far? 952 viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K November 23, 2020 0 Comments 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted November 23, 2020 0 Comments Annex 11 requires the audit trail review. Inspectors consider the release of batches to be the most critical process of all. Register or Login