What changed November 2023
The revised USP <797> chapter became official November 1, 2023 and materially raised the documentation bar. Differential pressure, temperature, and humidity must now be recorded continuously and retrievable on inspector demand. Manual logbooks no longer satisfy. State Boards of Pharmacy responded with intensified enforcement: Massachusetts found 36 of 40 inspected compounding pharmacies failed basic standards.
Who buys
- Independent compounding pharmacies (503A) and outsourcing facilities (503B)
- Hospital pharmacy compounding suites
- Veterinary compounding pharmacies
- University college of pharmacy education programs
- IV infusion centers and home infusion providers
Parameters monitored
- Differential pressure between cleanroom suites (continuous)
- Temperature & relative humidity (RH must remain < 60%)
- Particle counts to ISO Class 5/7/8 classifications
- Air change rates & viable air sampling integration
BHEIR fit
The most direct extension of our existing Caseore audit-trail engine. Inspection cycles, deviation workflows, CAPA, and document control map to the platform’s production-grade water-quality features. Our USP-aware reporting templates speak the chapter sections, the category language, and the BUD constraints inspectors arrive expecting.