Microbiological Best Laboratory Practices
Provides guidance on best practices for microbiological testing laboratories in pharmaceutical manufacturing environments, covering growth promotion, media preparation, incubation conditions, and analyst qualification.
Microbiological testing laboratories at pharmaceutical manufacturers producing sterile and non-sterile products. Complementary to USP <1116> for EM programmes.
- 01Growth promotion testing for all culture media with defined acceptance criteria
- 02Incubation temperature monitoring and documentation
- 03Analyst qualification programme for all microbiological procedures
- 04Out-of-specification investigation procedures specific to micro testing
Current revision 2022. Aligned with USP <1116> updates.
USP <1117>: frequently asked questions
Quick answers to common questions about USP <1117>.
What is USP <1117>?
USP <1117> — Microbiological Best Laboratory Practices — is a standard issued by the United States Pharmacopeia (United States / International). Provides guidance on best practices for microbiological testing laboratories in pharmaceutical manufacturing environments, covering growth promotion, media preparation, incubation conditions, and analyst qualification.
Who does USP <1117> apply to?
Microbiological testing laboratories at pharmaceutical manufacturers producing sterile and non-sterile products. Complementary to USP <1116> for EM programmes.
What are the key requirements of USP <1117>?
USP <1117> requires, among other things: Growth promotion testing for all culture media with defined acceptance criteria; Incubation temperature monitoring and documentation; Analyst qualification programme for all microbiological procedures; Out-of-specification investigation procedures specific to micro testing.
When was USP <1117> last updated?
The current version of USP <1117> dates from June 2022. Current revision 2022. Aligned with USP <1116> updates.
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.
Track the standards that move
When USP <1117> — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.