Type of Posting: Notice of Intent to Revise
Posting Date: 03-Feb–2025
Targeted Official Date: 01–Aug–2025
Expert Committee: Various
In accordance with the 2020–2025 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple monographs in response to a revision of General Chapter <1071> Rapid Microbiological Methods for the Detection of Contamination in Short-Life Products—A Risk-Based Approach.
General Chapter <1071> was proposed for comment in PF 50(1) and will become official on August 1, 2025. USP has identified other documentary standards referencing General Chapter <1071> impacted by the revisions in PF 50(1). These references were updated on February 3, 2025, and will become official on August 1, 2025. A list of the monographs that will be modified can be found here.
Interested stakeholders are encouraged to alert USP staff to any impact they recognize related to the update of those monographs.
Should you have any questions or comments, please contact Huiping Tu, Senior Principal Scientist (hpt@usp.org), or the affected monograph’s liaisons.