BRIEFING

 〈1113〉 Microbial Characterization, Identification, and Strain Typing. This proposal is based on the version of the monograph official prior to 2013. The Microbiology Expert Committee proposes the following revisions:

1. Provide clear identification strategies by sample type in Table 1.

2. Incorporate detailed, modern techniques such as matrix-assisted laser desorption ionization time of flight mass spectrometry (MALDI-TOF MS) and WGS.

3. This proposal provides in-depth descriptions of phenotypic, proteomic (MALDI-TOF MS), and genotypic methods as well as specifics on sample preparation, instrumentation, and limitations of each method.

4. Change Verification of Microbial Identification Methods to Qualification of Microbial Identification Methods including recommendations for accuracy, reproducibility, and database validation.

5. Update taxonomy and nomenclature to reflect current microbial taxonomy, encouraging the adoption of updated nomenclature with cross-references to legacy terms to support data continuity and trending.

6. Provide modernized and expanded definitions in the Glossary.

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

 (GCM: H. Tu)

 Case ID—SUB-2131