BRIEFING

 〈1071〉 Rapid Microbial Tests for Release of Sterile Short-Life Products: A Risk-Based Approach. This proposal is based on the version of the chapter official as of December 1, 2019. The Microbiology Expert Committee proposes the following revisions:

1. Change the title to “Rapid Microbiological Methods for the Detection of Contamination in Short-Life Products—A Risk-Based Approach”.

2. Redefine the application of rapid microbiological methods to short-life products.

3. Introduce a calculation to evaluate the probability of contamination and define an adequate sample volume.

4. Remove the limit of detection as the critical operation parameter to be used in determining a risk-based microbiological method.

5. Provide more guidance on the validation and suitability testing of the rapid microbiological method.

6. Update the example technologies to align with the USP Microbiology Expert Committee evaluation: ATP bioluminescence, nucleic acid amplification, respiration, and solid phase cytometry.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 The companion chapters Respiration-Based Microbiological Methods for the Detection of Contamination in Short-Life Products 〈72〉 and ATP Bioluminescence-Based Microbiological Methods for the Detection of Contamination in Short-Life Products 〈73〉 also appear in this issue of PF.

 (GCM: H. Tu)

 Correspondence Number—C326603