Application note: The correct use of Mean Kinetic Temperature in GxP environments
Posted: 15 December 2016 | Vaisala | No comments yet
In this application note Vaisala describe the origins of the value in GxP applications, how to perform the calculation, and give basic recommendations for its appropriate use.
Regulatory bodies and stakeholders in drug manufacturing and distribution have long been working together to create standards for temperature monitoring that will ensure the quality of drugs, devices and biotechnology. Over the last 15 years, the mean kinetic temperature (MKT) value has been identified as a potential tool for evaluating the impact of temperature on product quality.
Recently the calculation has come to be frequently misapplied in GxP-regulated industry. Originally the MKT was proposed to guide stability studies, but it’s now often used for evaluating temperature excursions as part of Good Distribution Practice. There is currently no consensus on how MKT should be applied. In this article we will describe the origins of the value in GxP applications, how to perform the calculation, and give basic recommendations for its appropriate use.
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