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Such reviews should normally be conducted and documented annually
Compendial methods taken from USP
An out of specification investigation must be completed each time a laboratory test
Your batch production record must accurately follow each step of the appropriate master manufacturing record
6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping Such reviews should normally beLabeling 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