Batch BT-020602
Celdurin • BSL • L003 • 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
2024-07-15 → 2024-07-25
Actual
2025-08-03 → 2025-11-25
Exceptions
7
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010612 | Titanium Dioxide | approved | Open workbench |
| LOT-010613 | Polyethylene Glycol 400 | approved | Open workbench |
| LOT-010614 | Polysorbate 80 | approved | Open workbench |
| LOT-010615 | Mannitol | quarantine | Open workbench |
| LOT-010616 | Sucrose | hold | Open workbench |
| LOT-010617 | Trehalose | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01012 HPLC System #13 | out-of-service | 2025-02-09 | qualified |
| AST-01013 UV-Vis Spectrophotometer #14 | cleaning-required | 2025-08-09 | requalification-due |
| AST-01014 Karl Fischer Titrator #15 | operational | 2025-01-06 | not-qualified |
| AST-01015 Dissolution Tester #16 | operational | 2026-09-05 | qualified |
| AST-01016 Hardness Tester #17 | operational | 2024-07-12 | qualified |
| AST-01017 Friability Tester #18 | in-calibration | 2025-04-30 | 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.