Type of Posting: Notice of Intent to Revise
Posting Date: 27-Jan-2023
Expert Committee: Packaging and Distribution Expert Committee
Mean Kinetic Temperature (MKT) cannot be used to normalize storage conditions situations that are out of control but can be a valuable tool to evaluate a temperature excursion. Thus, the use of MKT in evaluating a short-term excursion and the time frame used to calculate MKT as recommended by USP can allow for responsible management of excursion risk. Currently, <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products contains temperature excursion limits for climatic zone II.
The United States Pharmacopeia is pre-posting a revision to General Chapter <1079.2> where the inclusion of temperature excursion limits for climatic zone IVb is being proposed and a Stimuli Article: The Use of Mean Kinetic Temperature and the Need of Allowable Excursion Limits for Climatic Zone IVb which outlines the rationale for the revision, prior to its PF 49(2) [Mar.-Apr. 2023] publication.
This pre-posting is to allow stakeholders additional time for reading and understanding.
The chapter and Stimuli Article can be accessed here.
Questions may be directed to Desmond Hunt, Senior Principal Scientist, General Chapters (email@example.com).