Label Reconciliation

Label reconciliation is the process of accounting for the quantity of labels issued for a production run versus the number applied to finished product, with any discrepancy investigated. For dietary supplements it is required by 21 CFR 111.410(b) (Subpart L, Packaging and Labeling Operations): you must control the issuance and use of packaging and labels and reconcile any issuance/use discrepancies, unless a 100% examination for correct labels is performed by appropriate electronic or electromechanical equipment for cut or rolled labels. The drug cGMP rule (21 CFR 211.125) imposes the same reconciliation-with-exemption on finished pharmaceuticals. The purpose is to prevent obsolete, incorrect, or excess labels from being applied to the wrong products. Reconciliation is closely linked to changeover control: production line changeovers (switching from Product A to Product B) are where mislabeling errors most commonly occur.