USP <1117> - Microbiological Best Laboratory Practices

What it says

This chapter describes best practices for laboratories that perform microbiological tests, covering laboratory facilities, personnel competence, media and reagent preparation and quality control, equipment qualification and maintenance, culture handling, test performance, data recording and out-of-specification results. The goal is reliable and reproducible results.

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

What it means in practice

• Microbiological methods are variable by nature, so controls on media, cultures and technique matter a great deal.
• Analysts need documented training and ongoing competence checks.
• Culture maintenance and media growth promotion testing underpin the validity of results.

What inspectors look for

• Whether media are quality-controlled and growth promotion testing is done.
• Whether analyst competence is documented.
• Whether laboratory investigations follow a defined process.

Related regulations