ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 9.3: Restrict access to labels, reconcile labels issued, used and returned, destroy excess and obsolete labels, control printing devices and keep a representative label in the batch record

What does 9.3 require?

Access to label storage should be limited to authorised staff. Procedures should reconcile labels issued, used and returned and evaluate discrepancies between containers labelled and labels issued; discrepancies should be investigated with quality unit approval of the investigation. Excess labels printed with batch numbers or batch data should be destroyed, returned labels stored to prevent mix-ups, and obsolete or out-of-date labels destroyed. Printing devices should be controlled so the print matches the batch record. The labels issued to a batch should be examined for identity and conformity with the master production record and the result recorded, and a representative printed label kept in the batch record.