Systematic approaches to determining the disposition of temperature-compromised drug products: a regulatory and stability science–based review

Abstract Temperature excursions during storage, transportation, and handling across the pharmaceutical supply chain pose significant risks to the quality, safety, and efficacy of temperature-sensitive drug products. Vaccines, biologics, and injectable therapies rely on labeled storage conditions established through ICH Q1–compliant stability programs to maintain potency and limit degradation. When excursions occur, manufacturers and healthcare organizations must determine whether affected products remain suitable for use through science- and risk-based assessment. This review summarizes regulatory expectations from ICH, USP, CDC, EMA, and Health Canada and describes stability data and quality risk management approaches used to support product disposition decisions. Emphasis is placed on the appropriate use of stress testing, thermal cycling, transport simulation, and Mean Kinetic Temperature (MKT), as described in USP < 1079.2>. By integrating stability science with ICH Q12 lifecycle management principles, this article provides a practical framework for managing temperature excursions while protecting patient safety and minimizing unnecessary product loss.