6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping Such reviews should normally be

Such reviews should normally be conducted and documented annually

Microbiological pharmacopeia methods are considered to have been validated however the performance criteria and the suitability for each product type must be verified

and to propose necessary corrective measures

for example AOAC

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

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