BRIEFING

 〈1117〉 Microbiological Best Laboratory Practices. This proposal is based on the version of the chapter official as of August 1, 2025. The Microbiology Expert Committee is proposing a revision to this chapter with updated best practices. The changes include revisions to the following:

1. Preparation and Quality Control of Laboratory Media

   1. Media Preparation: Add details on the use of purified water, accurate weighing, and proper dissolution of media. Highlight the importance of avoiding overheating and using clean glassware.

   2. Media Transport and Storage: Include guidelines for proper labeling, storage conditions, and handling of media to prevent contamination and degradation.

   3. Quality Control and Receipt Testing: Expand on the need for quality control tests on all lots of prepared media and the importance of reviewing certificates of analysis from commercial vendors. Add a table for growth promotion options and acceptance criteria.

   4. Buffers and Reagents: Create a separate subsection.

2. Microbiological Media Incubation Times: Clarify the representation of incubation times in hours or days based on the duration of the test.

3. Laboratory Equipment: Add guidance on the qualification, calibration, and maintenance of laboratory equipment, including the importance of data integrity for equipment with software.

4. Sample Handling: Provide guidelines for aseptic sampling techniques, storage conditions, and documentation requirements for microbiological samples.

5. Considerations for Investigations and Microbiological Risk Assessments: Add more details for microbiological risk assessments and general principles for conducting risk assessments.

6. Method Transfer: Rewrite section to provide strategies for transferring analytical procedures, including comparative testing and waiver strategies.

7. Enumerative Microbiology: Rewrite of the Quantitative Microbiology section. Provides information on the practice of colony-forming units (CFU) enumeration and the importance of consistent criteria for distinguishing colonies. Included guidelines for second-person verification and the use of automated digital technology.

8. Data Integrity of Microbiological Data: Include application of the ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) principle and included challenges of manual microbiological methods and the use of automated enumeration methods.

9. Remove the sections for Using Modern Technologies, Qualification of Analysts, Documentation, Maintenance of Laboratory Records, and Investigations and incorporate the text into other relevant sections.

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

 (GCM: L. Furr)

 Case ID—SUB-1097