USP General Chapters
USP <62> - Microbiological Examination of Nonsterile Products - Tests for Specified Microorganisms
Plain-language explanation, inspection context and common violation patterns.
What it says
General Chapter <62> describes methodology for detecting the presence or absence of specified microorganisms considered objectionable for particular product types and routes of administration, complementing the general microbial enumeration described in Chapter <61>.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- Which specific organisms must be tested for under this chapter depends on the product's route of administration and intended patient population, connecting directly to the objectionable organism risk assessment required under 21 CFR 211.113.
- This chapter addresses presence or absence testing for specifically named organisms, distinct from the general microbial count enumeration addressed in Chapter <61>, and both are typically required together for a complete nonsterile product microbiological control programme.
- Method suitability testing confirming the product does not inhibit recovery of the specific target organisms is required before routine testing results can be considered valid.
What inspectors look for
- Whether the specific organisms tested for are correctly selected based on a documented, product and route-specific objectionable organism assessment.
- Whether method suitability testing for the specific target organisms has been performed for the actual product formulation.
- Whether a positive result for a specified objectionable organism triggers a documented investigation with appropriate rigor.
Most common violation
A generic, non-product-specific list of tested organisms applied across multiple different product types without a documented, individual objectionable organism risk assessment justifying that specific selection for each product.
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