GDP in the US: USP Chapter and Stimuli Article on MKT
Recommendation
Wednesday, 18 February 2026 9 .00 - 17.30 h
How to Audit Logistics Service Providers
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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.
Related GMP News
20.01.2026Documents to Support your GDP Audit
20.01.2026Questions and Answers on Transport and Vehicle Qualification (Part 3)
20.01.2026The GDP Non-Compliance Reports of 2025 - An Overview
16.12.2025How Valuable Are Commercial GDP Certificates?
16.12.2025Questions and Answers on Transport and Vehicle Qualification (Part 2)
16.12.2025When is a WDA Required? - Discussion of the ECA GDP Survey Results