How should you respond to a temperature excursion report?

• A. Record the excursion, quarantine affected stock, assess impact on potency, notify QA, and reposition stock as needed
• B. Quarantine affected stock, assess potency impact, notify QA
• C. Re-label items without testing
• D. Return stock to shelf immediately

Answer: (A)

Handling a temperature excursion focuses on containment, documentation, and proper disposition. The best approach is to record the excursion with details (date/time, exact temperatures, lot/stock affected, quantities), quarantine the affected stock to prevent use, assess the impact on potency and overall quality (including any necessary tests or stability considerations), notify QA so a formal deviation investigation and disposition can be issued, and reposition stock only after QA has determined its fate. This sequence preserves traceability, prevents distribution of potentially compromised product, and ensures the right people assess risk and decide whether, how, and when the stock can be used or must be discarded.

Quarantining and notifying QA without recording loses crucial traceability, while re-labeling without testing or returning to shelf without proper testing could mask or release quality problems.