Microbial Identification and Characterization Program Checklist

Program Scope and Level of Identification

Define what is identified and to what level.

• Is a procedure in place defining which isolates are identified and to what taxonomic level (genus vs species)? *
• Are isolates from Grade A/B environments, sterility tests, and excursions identified to species where feasible? *
• Is the level of identification risk-based relative to the criticality of the sample source? *

Methods and Reference Libraries

• Are identification methods (phenotypic, genotypic, or MALDI-TOF) validated or verified for the intended use? *
• Are reference databases and libraries current and appropriate for pharmaceutical isolates? *
• Are quality control organisms used to verify method performance? *

Objectionable Organisms and Investigations

• Are objectionable organisms defined based on product, route of administration, and patient population? *
• Are identifications used to support contamination investigations and root-cause analysis? *
• Is a characterized isolate library maintained to compare recurring contaminants?

Trending and Contamination Control

• Are identified organisms trended over time to detect shifts in the microbial flora? *
• Are identification results integrated into the contamination control strategy? *