Temperature Mapping for the Qualification of Storage Areas for Drug Products

Abstract: This article describes the use of temperature mapping as a process to qualify storage areas to maintain temperature for the storage of drugs, which is an effective strategy to identify risks as part of a quality management system.

The authors point out that maintaining temperature during storage is an important aspect to make sure that the safety, efficacy, and expiry of drugs are kept. This, of course, includes avoiding temperature excursions during storage. To evaluate if storage areas can adequately maintain the appropriate temperature, temperature mapping studies are necessary.

Best Practices • Chambers • Excursions • Monitoring • Qualification • Storage