Label issuance and control
Article 41
1. Access to the areas where labels are stored shall be limited to authorised personnel. 2. Procedures shall be used to reconcile the quantities of labels issued, used and returned, and to identify discrepancies between the number of containers labelled and the number of labels issued. Such discrepancies shall be investigated, and the investigation shall be approved by the quality unit. 3. All excess labels bearing batch numbers or other batch-related printing shall be destroyed. Returned labels shall be maintained and stored in a manner that provides proper identification and prevents mix-ups of labels. 4. Obsolete and outdated labels shall be destroyed, and such disposal be recorded. 5. Printing devices used to print labels for packaging operations shall be controlled to ensure that all imprinting conforms to the print specified in the batch production record. 6. Printed labels issued for a batch shall be carefully examined for proper identity and conformity with specifications in the master production record. The results of this examination shall be documented. 7. A printed label as used for the batch concerned shall be included in the batch production record.