Batch production and laboratory control records review
Article 28
1. Written procedures shall be established and followed for review and approval of batch production records referred to in Article 26 and laboratory control records referred to in Article 27, to ensure compliance of the active substance or intermediate thereof with established specifications before a batch is released. 2. Production and laboratory control records of non-critical process steps may be reviewed by qualified production personnel or other units following procedures approved by the quality unit. 3. All deviation, investigation, and out-of-specification reports shall be reviewed, as part of the batch record review, before the batch is released. 4. The quality unit can delegate the responsibility and authority for release of intermediates to the production unit, except for those intermediates dispatched outside the control of the manufacturer.