![]() ![]() Necessary cookies are absolutely essential for the website to function properly. 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. There is currently no consensus on how MKT should be applied. 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. Recently the calculation has come to be frequently misapplied in GxP-regulated industry. 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. 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. 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.
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