GDP in the US: Pre-posting of USP Chapter <1079.2> on MKT

On 02 December 2024, the United States Pharmacopeia (USP) issued a pre-posting notice to inform stakeholders of the anticipated publication of General Chapter <1079.2> in USP-NF 2025, Issue 2.

Background and Proposed Revision

General Chapter <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products "outlines the use of Mean Kinetic Temperature (MKT) to evaluate temperature excursions during the storage and transportation of drug products. While MKT cannot be used to normalize uncontrolled storage conditions, it serves as a valuable tool for assessing short-term excursions. The chapter currently includes temperature excursion limits for Climatic Zone II. The revised chapter will add temperature excursion limits for Climatic Zone IVb. A Stimuli Article titled The Use of Mean Kinetic Temperature and the Need for Allowable Excursion Limits for Climatic Zone IVb explains the rationale for this update."

The pre-posting provides early access to the chapter due to strong regulatory interest in several Climatic Zone IVb countries. The chapter and accompanying Stimuli Article can be accessed via the USP-NF website.

Please also see the news about the former Notice of Intent to revise General Chapter <1079.2> published in 2023.

The USP <1079> Series of Chapters on GDP

USP General Chapter <1079.2> is part of the <1079> series of chapters on Good Storage and Distribution Practices.

The current plan for the series is as follows:

• <1079> Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
• <1079.1> Storage and Transportation of Investigational Drug Products
• <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products
• <1079.3> Monitoring Devices—Time, Temperature, and Humidity
• <1079.4> Temperature Mapping for the Qualification of Storage Areas
• <1079.5> Qualification of Shipping Systems
• <1079.6> Transport Route Profiling Qualification
• <1079.7> Information Systems for Distribution Validation/Verification Studies