Microbiological Examination of Nonsterile Products
USP <61> covers microbiological examination of nonsterile products for total aerobic microbial count (TAMC) and total yeast and mold count (TYMC). USP <62> covers tests for specified microorganisms. Both are compendial standards required for product release.
All manufacturers of nonsterile pharmaceutical products (oral solids, creams, ointments, APIs) required to meet USP compendial standards for microbial limits.
- 01Method suitability testing demonstrating growth promotion in the presence of the product
- 02Standardised methodology for TAMC, TYMC, and specified organism tests
- 03Validated analytical procedures with documented suitability
- 04Retention of method suitability records linked to each test method
Current revision 2021. Terminology updated from "method validation" to "method suitability" to align with harmonised guidelines.
USP <61>/<62>: frequently asked questions
Quick answers to common questions about USP <61>/<62>.
What is USP <61>/<62>?
USP <61>/<62> — Microbiological Examination of Nonsterile Products — is a standard issued by the United States Pharmacopeia (United States / International). USP <61> covers microbiological examination of nonsterile products for total aerobic microbial count (TAMC) and total yeast and mold count (TYMC). USP <62> covers tests for specified microorganisms. Both are compendial standards required for product release.
Who does USP <61>/<62> apply to?
All manufacturers of nonsterile pharmaceutical products (oral solids, creams, ointments, APIs) required to meet USP compendial standards for microbial limits.
What are the key requirements of USP <61>/<62>?
USP <61>/<62> requires, among other things: Method suitability testing demonstrating growth promotion in the presence of the product; Standardised methodology for TAMC, TYMC, and specified organism tests; Validated analytical procedures with documented suitability; Retention of method suitability records linked to each test method.
When was USP <61>/<62> last updated?
The current version of USP <61>/<62> dates from May 2021. Current revision 2021. Terminology updated from "method validation" to "method suitability" to align with harmonised guidelines.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
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