According to the Code of Federal Regulations (CFR), 21 CFR 211.125 strict control shall be exercise over the labeling issued for use in drug product labeling operations. Issuing labels should be examined before use to ensure they conform to the master label. You need to reconcile the qualities of labels issued and investigate any discrepancies. There needs to be written procedures describing your control procedures for the issues of labeling.
A company recently received the following observation:
….. Procedures describing in sufficient detail the controls employed for the issuance of labeling are not written and followed.
Specifically, there are deficiencies in drug product labeling procedures.
a. There are no established procedures for documenting the control of drug product labeling by Quality Control. Documents, including, but not limited to the examples below, only record the firm’s receipt dates of labeling and labeling components.
i. Labeling Log Book
ii. Labeling Component
iii. Labeling Component Inventory Record
Quality Control approval to release labeling, issuance of labeling, and the return to labeling storage stock, are not specified in any written procedures, or, fully documented in these records.
b. Apparent discrepancies and/or incomplete documentation of packaging and labeling components were found in Manufacturing Batch Records, including, but not limited to the records listed below.
i. A Packing slip shows the sale of all … lots listed above, but no apparent documentation for annual label reconciliation.
ii. The labeling reconciliation report for …, states … labels were received by manufacturing; … were used; and … were rejected. This would be a total of … labels remaining. However, the Production Operators documented that … labels were returned to stock.
For additional information pertaining to packaging and issuing labels, refer to FDA Presentation: Packaging and Labeling. To view more observations pertaining to labeling, refer to the following GMP Trends® Issues: 1088, 1074, 1069, and 1064.
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