GDP in the US: USP Chapter and Stimuli Article on MKT

In the Pharmacopeial Forum, PF 49(2), a proposal for a revised USP General Chapter <1079.2> "Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products" and a Stimuli Article "The Use of Mean Kinetic Temperature and the Need of Allowable Excursion Limits for Climatic Zone IVb" were published.

The background is that the United States Pharmacopeia (USP) is proposing the inclusion of temperature excursion limits for climatic zone IVb. Currently, Chapter  <1079.2> contains only temperature excursion limits for climatic zone II.

As already reported in February, both documents, the revised Chapter <1079.2> and the Stimuli Article, were pre-posted prior to their publication in the Pharmacopeial Forum. According to the USP, this was to allow stakeholders additional time for reading and understanding.

For a summary of the changes and contents, please have a look at our news archive.

The documents are available on PF Online. Comments can be submitted until 31 May 2023.