USP <1113> - Microbial Characterization, Identification and Strain Typing

What it says

This chapter provides guidance on the characterization and identification of microorganisms recovered from pharmaceutical processes, environments, personnel and products, including phenotypic and genotypic methods and strain typing. It describes when identification is useful, for example for investigations and trending, and how to choose a suitable method.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Identifying isolates to genus or species level helps to find the source of contamination.
• Identification supports trending, which can reveal shifts in the flora of a cleanroom.
• The depth of identification should match the risk, with more effort for higher-grade areas and for investigations.

What inspectors look for

• Whether isolates from critical areas and failures are identified.
• Whether identification data are used in investigations and trended.
• Whether the identification method is suitable and validated.

Related regulations