Batch BT-020542
Celdurin • CMO1 • L043 • completed
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
2026-09-26 → 2026-10-07
Actual
2025-01-16 → 2025-02-14
Exceptions
24
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010794 | Polysorbate 80 Variant 6 | approved | Open workbench |
| LOT-010795 | Mannitol Variant 6 | quarantine | Open workbench |
| LOT-010796 | Sucrose Variant 6 | hold | Open workbench |
| LOT-010797 | Trehalose Variant 6 | rejected | Open workbench |
| LOT-010798 | Histidine Buffer Variant 6 | expired | Open workbench |
| LOT-010799 | Sodium Chloride Variant 6 | consumed | Open workbench |
| LOT-010800 | Water for Injection Variant 6 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01194 Shrink Wrapper #195 | out-of-service | 2026-02-07 | not-qualified |
| AST-01195 Checkweigher #196 | cleaning-required | 2026-01-16 | qualified |
| AST-01196 Metal Detector #197 | operational | 2025-06-22 | qualified |
| AST-01197 X-Ray Inspection #198 | operational | 2025-12-15 | qualified |
| AST-01198 Leak Tester #199 | operational | 2025-06-05 | requalification-due |
| AST-01199 Torque Tester #200 | in-calibration | 2025-12-15 | not-qualified |
| AST-01200 Granulator #201 | in-maintenance | 2026-09-10 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | major | under-review | dev-00543 |
| Procedure Deviation | major | under-review | dev-00043 |
| Procedure Deviation | major | under-review | dev-01043 |
| Procedure Deviation | major | under-review | dev-00543 |
| Procedure Deviation | major | under-review | dev-00043 |
| Procedure Deviation | major | under-review | dev-01043 |
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.