How should test article labeling be designed?

• A. Common descriptive names only.
• B. No labeling needed.
• C. Unique identifiers, lot numbers, expiration dates, and storage conditions with proper documentation.
• D. Only the expiration date.

Answer: (C)

Labeling test articles must enable traceability and safe handling across the study. The best approach includes unique identifiers that stay with the item, lot numbers to link to production records, expiration dates to ensure materials are used within their stability window, and storage conditions so the material is kept under the proper environment. When these elements are documented and maintained, there is a complete record showing where each item came from, how it was stored, and when it was used, which supports data integrity, inventory control, and regulatory compliance. Using only descriptive names can’t reliably distinguish between batches, making mix-ups or misidentification possible. Relying on just an expiration date omits critical information about origin and storage, risking improper use. No labeling at all eliminates any way to identify or track the material, which is unacceptable. Comprehensive labeling with unique IDs, lot numbers, expiration dates, and storage conditions, plus proper documentation, provides the necessary control and traceability required by GLP.