Type of Notice: General Announcement
Posting Date: 01-Nov-2024
This is a follow up to the General Announcement <86> Bacterial Endotoxins Test Using Recombinant Reagents posted on the USP website August 22, 2023.
Just as comments to <1085.1> Use of Recombinant Reagents in the Bacterial Endotoxins Test were made public in 2020, USP is publishing comments received on the proposed chapter <86>.
As stated in the chapter briefing from the publication in Pharmacopeial Forum PF 49(6) [Nov.-Dec. 2023]:
Under the Rules and Procedures of the Council of Experts, all comments submitted to USP in response to proposals published in the Pharmacopeial Forum, as well as the identities of the commenters, are considered public information unless clearly and specifically designated as confidential.
Stakeholder Comments
Individual
Pharmaceutical and Regulatory
Environmental Organizations
Reagent Manufacturers
Frequently Asked Questions (FAQ)
Additionally, USP is providing updated responses and clarifications as Frequently Asked Questions (FAQs).
Additional Materials
In order to facilitate the adoption of these technologies when <86> is published in the USP-NF, USP is providing recombinant reagent materials from the recent workshop USP Modern Methods for Endotoxins and Pyrogens Testing Virtual Workshop held May 14-15, 2024.
Recordings from the recombinant reagents session from the workshop are also being made available again through the end of the year. Please follow this link to access video recording.
MM workshop bios and summaries.pdf
MM Workshop Recombinant Slide Decks.pdf
Should you have any questions or comments, please contact Leslie Furr, Senior Scientist II, at microbiology@usp.org.