Batch BT-020362
Celdurin • BSL • L013 • 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
2024-03-07 → 2024-03-20
Actual
2026-07-15 → 2025-10-08
Exceptions
19
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011086 | Magnesium Stearate Variant 6 | expired | Open workbench |
| LOT-011087 | Croscarmellose Sodium Variant 6 | consumed | Open workbench |
| LOT-011088 | Povidone K30 Variant 6 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01286 Bioreactor #287 | cleaning-required | 2025-09-30 | qualified |
| AST-01287 Centrifuge #288 | operational | 2025-05-15 | qualified |
| AST-01288 Lyophilizer #289 | operational | 2026-01-06 | requalification-due |
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.
Release Readiness: BT-020362
Score: 82
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.