Batch BT-020842
Celdurin • BSL • 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
2024-06-12 → 2024-06-25
Actual
2025-10-22 → 2024-10-01
Exceptions
1
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010736 | Sucrose Variant 4 | consumed | Open workbench |
| LOT-010737 | Trehalose Variant 4 | in-process | Open workbench |
| LOT-010738 | Histidine Buffer Variant 4 | approved | Open workbench |
| LOT-010739 | Sodium Chloride Variant 4 | approved | Open workbench |
| LOT-010740 | Water for Injection Variant 4 | approved | Open workbench |
| LOT-010741 | Purified Water Variant 4 | quarantine | Open workbench |
| LOT-010742 | Ethanol 95% Variant 4 | hold | Open workbench |
| LOT-010743 | Isopropyl Alcohol Variant 4 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01252 HPLC System #253 | operational | 2025-08-30 | qualified |
| AST-01253 UV-Vis Spectrophotometer #254 | operational | 2025-03-08 | requalification-due |
| AST-01254 Karl Fischer Titrator #255 | operational | 2025-02-12 | not-qualified |
| AST-01255 Dissolution Tester #256 | in-calibration | 2026-02-15 | qualified |
| AST-01256 Hardness Tester #257 | in-maintenance | 2025-07-11 | qualified |
| AST-01257 Friability Tester #258 | out-of-service | 2026-10-02 | 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.