Written procedures are to be established and followed for a time efficient and clear evidence of the quality related elements during the review and approval for release, including packaging and labeling, to determine compliance of the intermediates (FDA definition) and/or finished product with established specifications before a batch can be released for distribution BPRs, DHRs and laboratory control records for critical process steps are to be reviewed and approved by the quality unit(s) before a finished product batch is released for distribution. Production and laboratory control records for earlier, non-critical process steps may be reviewed by qualified production personnel or other units following procedures approved by the quality unit(s). All incidents or deviations, investigation, and OOS, OOT, OOL reports should be reviewed to ensure there is no
product quality impact by providing technically written sound scientific rationale for the assessment and conclusion as part of the batch record review before the batch is released.
product quality impact by providing technically written sound scientific rationale for the assessment and conclusion as part of the batch record review before the batch is released.
