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Your batch production record must accurately follow each step of the appropriate master manufacturing record
Such reviews should normally be conducted and documented annually
for example AOAC
experience with the process and ultimately links to the protection of the patient
There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components
6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping Your batch production record mustLabeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records. Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found
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