Pharmaceutical Manufacturing Handbook: Production and

Label Issuance and Control
• Access to the label storage areas should be limited to authorized personnel.
• Procedures should be used to reconcile the quantities of labels issued, used,
and returned and to evaluate discrepancies found between the number of containers
labeled and the number of labels issued. Such discrepancies should be
investigated and the investigation should be approved by the quality unit(s).
• 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 identifi cation.
• Obsolete and outdated labels should be destroyed.
• Printing devices used to print labels for packaging operations should be controlled
to ensure that all imprinting conforms to the print specifi ed in the batch
production record.
• Printed labels issued for a batch should be carefully examined for proper identity
and conformity to specifi cations in the master production record. The
results of this examination should be documented.
• A printed label representative of those used should be included in the batch
production record.
Packaging and Labeling Operations
REGULATORY ASPECTS 197
• There should be documented procedures designed to ensure that correct packaging
materials and labels are used.
• Labeling operations should be designed to prevent mix - ups. There should be
physical or spatial separation from operations involving other intermediates or
APIs.
• 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 API.
• 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 certifi cate of analysis. For intermediates or APIs with a retest date,
the retest date should be indicated on the label and/or certifi cate of analysis.
• Packaging and labeling 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.
• Packaged and labeled 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.