Application note

Mean kinetic temperature (MKT) is widely referenced in GxP-regulated environments as a tool for assessing the cumulative impact of temperature on product quality. While originally developed for stability studies, MKT is now frequently discussed in the context of temperature excursions in Good Distribution Practice (GDP) applications.

However, MKT is often misunderstood and misapplied. Regulatory guidance varies, the calculation is non-linear, and MKT must never be used as a substitute for proper temperature control or excursion investigation.

This application note explains the regulatory background, scientific basis, and appropriate use of MKT, including where it adds value—and where it does not—in GxP-compliant storage and distribution.