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There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components
experience with the process and ultimately links to the protection of the patient
in the case of certain OTC drug products exempted from expiration dating
You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies
Your batch production record must accurately follow each step of the appropriate master manufacturing record
6.3 - Production - Packaging and Labeling Operations Records & Recordkeeping There shall be a qualityLabeling 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