Batch BT-020866
Aziroline PED • BSL • L017 • released
About this view
This batch detail page ties execution evidence, material genealogy, equipment fitness, in-process controls, and quality events into one release-focused view. Users can trace each unit operation against timestamps and investigate linked exceptions without leaving context. The panelized layout supports QA review by exception while preserving full evidence access. Next actions include closing residual issues and completing disposition-ready evidence checks.
Planned
2026-07-07 → 2026-07-12
Actual
2026-01-03 → 2026-01-06
Exceptions
12
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010928 | Sodium Hydroxide | approved | Open workbench |
| LOT-010929 | Phosphoric Acid | approved | Open workbench |
| LOT-010930 | Active Pharmaceutical Ingredient A Variant 1 | quarantine | Open workbench |
| LOT-010931 | Active Pharmaceutical Ingredient B Variant 1 | hold | Open workbench |
| LOT-010932 | Active Pharmaceutical Ingredient C Variant 1 | rejected | Open workbench |
| LOT-010933 | Microcrystalline Cellulose Variant 1 | expired | Open workbench |
| LOT-010934 | Lactose Monohydrate Variant 1 | consumed | Open workbench |
| LOT-010935 | Hydroxypropyl Methylcellulose Variant 1 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01396 Metal Detector #397 | in-maintenance | 2024-07-09 | qualified |
| AST-01397 X-Ray Inspection #398 | out-of-service | 2024-12-22 | qualified |
| AST-01398 Leak Tester #399 | cleaning-required | 2025-03-11 | requalification-due |
| AST-01399 Torque Tester #400 | operational | 2024-12-04 | not-qualified |
| AST-01000 Granulator #1 | operational | 2025-09-25 | qualified |
| AST-01001 Tablet Press #2 | operational | 2024-08-06 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
QA Review Checklist and Signatures
- Step execution completeness verified with signed evidence.
- All high-severity exceptions dispositioned or justified.
- QC release tests reviewed and OOS investigations closed or dispositioned.
- Final release signatory validated with segregation-of-duties check.
No release readiness record found.