Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion...

If a temperature-controlled IP has experienced a temperature excursion during transport, the appropriate action is to register the IP in the Interactive Web Response System (IWRS), quarantine it to prevent use, and immediately notify the sponsor. This procedure ensures that the IP is not used until the sponsor evaluates its stability and suitability.

GCP guidelines state that any IP affected by a temperature excursion should be quarantined and reported to the sponsor for evaluation.

"Upon identification of a temperature excursion, the IP must be quarantined and reported to the sponsor to determine its usability."

Objectives:

Maintain IP integrity and compliance with storage conditions.

Follow protocol for managing temperature excursions.