Modules
Master Formulas
Recipe management with versioning, BOM, and approval workflows
Master Formulas
Master Formulation Records (MFRs) are the validated recipes from which every batch is compounded.
Concepts
A formula consists of three major components:
| Component | Description |
|---|---|
| Header | Name, strength, dosage form, USP category, storage conditions |
| Bill of Materials | Ingredients with quantities, units, tolerance ranges |
| Step Definitions | Ordered instructions with equipment, parameters, and signature requirements |
Formula Lifecycle
Draft <Icon name="ArrowRight" size={12} /> Approved <Icon name="ArrowRight" size={12} /> Superseded (when new version created)Versioning Rules
- Every edit to an approved formula creates a new version (v2, v3, ...)
- Batch records reference a specific formula version — immutable binding
- Only one version can be in
approvedstatus at a time supersededversions are read-only but fully viewable
Business Rules
| Rule | Description |
|---|---|
| F1 | Only PIC can approve a formula (draft approved) |
| F2 | Approval requires e-signature with meaning "Approved for production" |
| F3 | BOM quantities must have defined tolerance ranges |
| F4 | Steps cannot have duplicate sequence numbers |
| F5 | Equipment referenced must have active status and current calibration |
| F6 | HD formulas must flag hazardous drug requirements |
BUD Categories
| Category | CRT (20–25°C) | Refrigerated (2–8°C) | Frozen (≤ -20°C) |
|---|---|---|---|
| 1 | 12 hours | 12 hours | 12 hours |
| 2 | 1 day | 4 days | 45 days |
| 3 | 1 day | 4 days | 45 days* |
*Category 3 allows extended dating with sterility testing.