6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping Microbiological pharmacopeia methods are considered

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

You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies

Such reviews should normally be conducted and documented annually

Your batch production record must accurately follow each step of the appropriate master manufacturing record

6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping Microbiological pharmacopeia methods are consideredLabeling 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