6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping experience with the process and

experience with the process and ultimately links to the protection of the patient

and to propose necessary corrective measures

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

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

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

6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping experience with the process andLabeling 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