9. PACKAGING AND IDENTIFICATION LABELLING OF APIs AND INTERMEDIATES

9. PACKAGING AND IDENTIFICATION LABELLING OF APIs AND INTERMEDIATES
9.1 General
9.10 There should be written procedures describing the receipt, identification, quarantine, sampling, examination and/or testing and release, and handling of packaging and labelling materials.
9.11 Packaging and labelling materials should conform to established specifications. Those that do not comply with such specifications should be rejected to prevent their use in operations for which they are unsuitable.
9.12 Records should be maintained for each shipment of labels and packaging materials showing receipt, examination, or testing, and whether accepted or rejected.
9.2 Packaging Materials
9.20 Containers should provide adequate protection against deterioration or contamination of the intermediate or API that may occur during transportation and recommended storage.
9.21 Containers should be clean and, where indicated by the nature of the intermediate or API, sanitized to ensure that they are suitable for their intended use. These containers should not be reactive, additive, or absorptive so as to alter the quality of the intermediate or API beyond the specified limits.
9.22 If containers are re-used, they should be cleaned in accordance with documented procedures and all previous labels should be removed or defaced.
9.3 Label Issuance and Control
9.30 Access to the label storage areas should be limited to authorised personnel.
9.31 Procedures should be used to reconcile the quantities of labels issued, used, and returned and to evaluate discrepancies found between the number of containers labelled and the number of labels issued. Such discrepancies should be investigated, and the investigation should be approved by the quality unit(s).
9.32 All excess labels bearing batch numbers or other batch-related printing should be destroyed. Returned labels should be maintained and stored in a manner that prevents mix-ups and provides proper identification.
9.33 Obsolete and out-dated labels should be destroyed.
9.34 Printing devices used to print labels for packaging operations should be controlled to ensure that all imprinting conforms to the print specified in the batch production record.
9.35 Printed labels issued for a batch should be carefully examined for proper identity and conformity to specifications in the master production record. The results of this examination should be documented.
9.36 A printed label representative of those used should be included in the batch production record.
9.4 Packaging and Labelling Operations
9.40 There should be documented procedures designed to ensure that correct packaging materials and labels are used.
9.41 Labelling operations should be designed to prevent mix-ups. There should be physical or spatial separation from operations involving other intermediates or APIs.
9.42 Labels used on containers of intermediates or APIs should indicate the name or identifying code, the batch number of the product, and storage conditions, when such information is critical to assure the quality of intermediate or API.
9.43 If the intermediate or API is intended to be transferred outside the control of the manufacturer’s material management system, the name and address of the manufacturer, quantity of contents, and special transport conditions and any special legal requirements should also be included on the label. For intermediates or APIs with an expiry date, the expiry date should be indicated on the label and Certificate of Analysis. For intermediates or APIs with a retest date, the retest date should be indicated on the label and/or Certificate of Analysis.
9.44 Packaging and labelling facilities should be inspected immediately before use to ensure that all materials not needed for the next packaging operation have been removed. This examination should be documented in the batch production records, the facility log, or other documentation system.
9.45 Packaged and labelled intermediates or APIs should be examined to ensure that containers and packages in the batch have the correct label. This examination should be part of the packaging operation. Results of these examinations should be recorded in the batch production or control records.
9.46 Intermediate or API containers that are transported outside of the manufacturer's control should be sealed in a manner such that, if the seal is breached or missing, the recipient will be alerted to the possibility that the contents may have been altered.