Mean Kinetic Temperature In GxP Environments / Definitions And Applications

Regulatory bodies and stakeholder organizations in drug and device manufacturing and distribution have long been working toward creating standards for temperature monitoring that ensure the shelf life, quality and safety of products. In the last 15 years of these ongoing efforts, mean kinetic temperature (MKT) has been identified as one of the potential tools available for evaluating the impact of temperature on product quality.

MKT can be a difficult tool to understand and apply properly. MKT was first proposed to guide stability studies, and is now considered as a tool for evaluating temperature excursions in the dynamic arena of Good Distribution Practices. The math is difficult for most laypersons, and there is not a consensus on how MKT should be applied.