Pharmacopoeia
United States Pharmacopeia–National Formulary
Published by US Pharmacopeial Convention
The legal standard for medicines in the US and a reference for many export markets. Its microbiology chapters are harmonised with Ph. Eur. and JP.
Why it matters to you: If your product is sold in the US or your customer's specification cites USP, these chapters define your tests and limits.
Key references for microbiology
| Reference | Topic | In short |
|---|---|---|
| <61> | Microbial enumeration | TAMC and TYMC, method suitability |
| <62> | Specified micro-organisms | E. coli, Salmonella, P. aeruginosa, S. aureus, Clostridia, C. albicans |
| <71> | Sterility tests | Membrane filtration and direct inoculation, 14 days |
| <85> | Bacterial endotoxins | Gel clot, turbidimetric, chromogenic |
| <86> | Endotoxins with recombinant reagents | rFC and recombinant cascade |
| <1111> | Acceptance criteria for non-sterile products | Limits by route of administration |
| <1116> | Aseptic processing environments | Recovery-rate trending, EM design |
| <1231> | Water for pharmaceutical purposes | Systems, sanitisation, action levels |
| <1072> | Disinfectants and antiseptics | Efficacy testing, log reductions |
| <1223> | Alternative methods validation | Rapid methods equivalence |
Practical tips
- Chapters numbered 1000 and above are informational, but inspectors expect you to have considered them.
- Track 'official from' dates of each revision and assess impact through change control.
Learn and test yourself
Other standards
Summarised in our own words for learning. Always refer to the current official text for exact requirements. How we use references