Mean Kinetic Temperature in GxP environments


In recent years, mean kinetic temperature (MKT) has been identified as a potential tool for evaluating the impact of temperature on product quality. However, the calculation can be difficult, and is often misused.

MKT was first proposed to guide stability studies and is now considered useful for understanding temperature excursions in GDP-compliant applications. The math is tough, and there is currently no consensus on how the calculation should be applied.

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