USP Publishes Summary of Comments on Chapter <1079.2> Regarding Mean Kinetic Temperature (MKT)

As reported in our December newsletter, the United States Pharmacopeia (USP) recently issued a pre-posting notice regarding the anticipated publication of General Chapter <1079.2>, titled "Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products."

The USP has now provided commentary for USP–NF 2025, Issue 2. The document, dated 03 February 2025, covers various chapters, including <1079.2>, and addresses stakeholder feedback on the proposed revisions.

Several comments were submitted concerning the practical application and regulatory impact of the Mean Kinetic Temperature (MKT) approach. The document outlines 15 points, though most suggestions were not incorporated.

For instance, one commenter highlighted the large amount of data generated during product storage and requested clarification on whether all data must be considered when calculating the Mean Kinetic Temperature. The USP clarified that all available data must be used.

Regarding the scope of the chapter, stakeholders asked whether it applies only to drug products manufactured, stored, and distributed within the USA or North America, or if it has a global scope. The USP confirmed that the chapter was written as a global document.

A suggestion to define acceptable limits for repeated deviations was also not adopted. The USP reasoned that repeated deviations indicate a lack of system control, and manufacturers are responsible for establishing their own limits for multiple excursions within the supply chain.

For further details, the full commentary is available as a PDF file on the USP website.