6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping and to propose necessary corrective

and to propose necessary corrective measures

Compendial methods taken from USP

in the case of certain OTC drug products exempted from expiration dating

An out of specification investigation must be completed each time a laboratory test

6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping and to propose necessary correctiveLabeling 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