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.
What this does not cover
stated in the document's own scope- Provides informational best practice; it does not set the mandatory acceptance criteria for a specific microbial test — those live in the enforceable chapters below <1000>.
- Covers laboratory practices, not the environmental monitoring of cleanrooms in production, which is the subject of USP <1116>.
- Is a US compendial chapter; the equivalent principles in Europe are carried through the European Pharmacopoeia’s general texts.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
USP General Chapter <1117>, Microbiological Best Laboratory Practices, is guidance on how to run a pharmaceutical microbiology laboratory well. It covers the practical foundations that determine whether microbiological results can be trusted: preparation and quality control of culture media, growth-promotion testing, handling and storage of reference cultures, incubation conditions, sterilisation and decontamination, laboratory layout and workflow to control contamination, and the training and qualification of analysts. It is written as recommended practice rather than as pass/fail acceptance criteria for a specific test.
Scope & applicability
Microbiological testing laboratories at pharmaceutical manufacturers producing sterile and non-sterile products. Complementary to USP <1116> for EM programmes.
Legal basis & how it acquires force
Chapter <1117> is part of the United States Pharmacopeia–National Formulary (USP–NF). Its number matters: USP general chapters numbered above 1000 are informational and are not mandatory unless a monograph or another applicable requirement calls them into force. So <1117> is best-practice guidance, whereas the microbiological test chapters it supports — such as <61>, <62>, and <71>, all numbered below 1000 — are enforceable when a monograph references them. In the US, USP–NF standards become legally enforceable through the Federal Food, Drug, and Cosmetic Act where they apply.
Document structure
| Part | Covers |
|---|---|
| Media preparation and QC | Preparing, sterilising, and quality-controlling culture media, including growth promotion |
| Cultures and reference strains | Sourcing, maintaining, storing, and passaging reference cultures |
| Incubation and equipment | Incubation conditions and the control and monitoring of laboratory equipment |
| Laboratory layout and contamination control | Workflow, environmental control, and sterilisation/decontamination to protect results |
| Personnel and documentation | Analyst training, aseptic technique, and record practices |
Key requirements
- 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
Revision notes
Current revision 2022. Aligned with USP <1116> updates.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Chapter <1117> supports the compendial microbial-enumeration and sterility chapters (<61>, <62>, <71>) by describing the laboratory conditions under which those tests give reliable results. It complements <1116> on environmental monitoring of aseptic processing and sits within the broader compendial microbiology framework rather than duplicating any single mandatory method.
USP <1117>: frequently asked questions
Quick answers to common questions about USP <1117>.
Is USP <1117> mandatory?
No. USP general chapters numbered above 1000 are informational. <1117> is best-practice guidance; the enforceable microbiological tests it supports — such as <61>, <62>, and <71> — are numbered below 1000 and apply when a monograph references them.
What does USP <1117> cover?
Best practices for running a pharmaceutical microbiology laboratory: media preparation and growth-promotion testing, reference-culture handling, incubation, contamination control, equipment, and analyst qualification.
How does <1117> relate to <1116>?
Chapter <1117> covers microbiology laboratory practices; <1116> covers the microbiological environmental monitoring of aseptic processing in production. They are complementary chapters addressing different settings.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.