Compliance
USP 797
Sterile compounding standards compliance
USP <797> Compliance
Clarix is designed to support compliance with USP <797> — the United States Pharmacopeia chapter governing pharmaceutical compounding of sterile preparations.
Key Requirements
Personnel Qualification
| Requirement | Clarix Implementation |
|---|---|
| Training documentation | Training module tracks all personnel qualifications |
| Competency assessment | Competency assessments recordable per user |
| Media fill qualification | Auto-expiring 6-month qualification with batch assignment blocking |
| Garbing qualification | Annual garbing assessment tracking |
| Hand hygiene | Gloved fingertip testing results recordable |
Facilities & Engineering
| Requirement | Clarix Implementation |
|---|---|
| ISO classification | Room map with ISO 5/7/8 classification per area |
| Temperature monitoring | Manual or sensor-based temperature logging |
| Pressure differentials | Recordable per room with trend tracking |
| HEPA certification | Equipment module tracks HEPA filter certification dates |
Environmental Monitoring
| Requirement | Clarix Implementation |
|---|---|
| Viable air sampling | EM module with scheduled sampling points |
| Viable surface sampling | Configurable sampling locations per room |
| Non-viable particles | Particle count data entry and trending |
| Alert/action limits | Auto-checking against configurable limits |
| Excursion management | Auto-created excursions with batch impact assessment |
| Trend analysis | Statistical trending charts per room/point |
Compounding Process
| Requirement | Clarix Implementation |
|---|---|
| Master formulation record | Formula module with versioning and approval |
| Compounding record | Digital batch record with step-by-step execution |
| Component verification | Barcode scanning for material verification |
| BUD assignment | Auto-calculated based on USP category |
| Labeling | Auto-generated labels with required information |
Quality Assurance
| Requirement | Clarix Implementation |
|---|---|
| Sterility testing | Lab samples module with batch linkage |
| Endotoxin testing | Test results with specification limits |
| Visual inspection | Photo capture in batch execution |
| Deviation management | Quality module with full investigation workflow |
| CAPA | CAPA lifecycle with effectiveness verification |
Documentation Requirements
USP <797> requires documentation to be:
- Legible — digital records eliminate handwriting issues
- Indelible — INSERT-only audit trail prevents alteration
- Retrievable — full-text search and export capabilities
- Retained — minimum 3 years, configurable per state requirements
BUD Assignment
Clarix auto-calculates BUD based on the revised USP <797> categories:
Category 1 (12 hours all conditions)
- Compounded in ISO 5 or better
- No sterility testing performed
- BUD = 12 hours regardless of storage
Category 2 (1–45 days)
- Compounded in ISO 5 within ISO 7 with ISO 8 ante-area
- No sterility testing performed
- BUD varies by storage temperature
Category 3 (extended dating)
- Same facility requirements as Category 2
- Sterility testing performed per USP <71>
- Extended dating supported with stability data