Drug Substance / Drug Product Production Labels – GMP labels applied to drug substance or clinically packaged drug product containers that identify the material name, lot/batch number, retest/expiry, storage conditions, caution statements, and other information critical to the traceability and use of the of the material.

Why it Matters – Regulatory agencies require strict control of label content and generation, inspection/release, issuance, use, and reconciliation of all labels used in labeling of drug substances and drug products including damaged labels, those applied to batch records, and labels remaining after the production is concluded.

Case Study – A client had two very different active pharmaceutical ingredients (API) manufactured at a drug substance manufacturing site.  Both API’s were produced, tested, and the bulk drum containers for each API lot were labeled.  The bulk container for one of the active ingredients was shipped to a drug product manufacturer to be formulated and pressed into tablets.  The drug product manufacturer received the active ingredient and a QC analyst sampled and tested the material to confirm its identify.  The result failed. 

An Out of Specification (OOS)  investigation was opened and confirmatory testing was initiated.  This too failed the identification test.  The analyst inspected the bulk container label and verified that the material name and lot number matched the certificate of analysis that was provided with the shipment.  Needing additional help to resolve the issue, the analyst emailed the drug substance manufacturer attaching the test results she obtained along with a photograph of the bulk container label. 

A few weeks later (yes, it took that long), the manufacturer replied to the analyst and told her that they had incorrectly labeled the bulk API container with the information from the other active ingredient that they manufactured for the same client.

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