Revision of USP chapter <1071> on rapid methods and its effect on other USP chapters

Recommendation

11/12 March 2025
Berlin, Germany

Microbiology for Non-Microbiologists
Understand the „true“meaning of microbiological findings

Background

The comment period for the revised chapter <1071> of the United States Pharmacopoeia (USP) “Rapid Microbial Tests for Release of Sterile Short-Life Products: A Risk-Based Approach” ended last March, when the following changes were listed by the USP:

Change the title to “Rapid Microbiological Methods for Detecting Contamination in Short-Life Products - A Risk-Based Approach”.
Redefinition of the use of rapid microbiological methods for short shelf life products.
Introduction of a calculation to assess the probability of contamination and to determine an appropriate sample volume.
Removal of the detection limit as a critical operational parameter to be used when establishing a risk-based microbiological method.
Provide further guidance on the validation and proficiency testing of the rapid microbiological method.
Update the example technologies to align with the USP Expert Committee on Microbiology assessment: ATP bioluminescence, nucleic acid amplification, respiration and solid phase cytometry

Current effects

The implementation of the new chapter is currently planned for August 2025. Therefore, in accordance with its Rules and Procedures of the Council of Experts, the USP makes it known that other chapters or documents will be affected by the revision of <1071> and that the USP and its expert committees intend to revise several monographs in response to the revision of General Chapter <1071>:

Chapter Guide: Vaccines
Chapter Guide: Gene and Cell Therapy Products
Chapter Guide: Microbiology Products
<1117> MICROBIOLOGICAL BEST LABORATORY PRACTICES
<1046> CELL-BASED ADVANCED THERAPIES AND TISSUE-BASED PRODUCT

Interested stakeholders are asked to bring to the attention of USP staff any implications they recognize in connection with the update of these monographs.

Further details can be found after registration on the Webpage of the USP

In this context, please note the European Microbiology Conference on May 20-22 in Vienna, where 2 representatives of the USP Expert Group will present the latest amendments of USP chapters with microbiological topics.