Batch BT-020452
Celdurin • DUB • 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
2026-07-30 → 2026-08-11
Actual
2024-06-18 → 2026-07-08
Exceptions
17
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011808 | Povidone K30 | in-process | Open workbench |
| LOT-011809 | Talc | approved | Open workbench |
| LOT-011810 | Colloidal Silicon Dioxide | approved | Open workbench |
| LOT-011811 | Stearic Acid | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01364 Blender #365 | operational | 2025-04-05 | not-qualified |
| AST-01365 Autoclave #366 | operational | 2025-03-29 | qualified |
| AST-01366 Bioreactor #367 | operational | 2024-08-10 | qualified |
| AST-01367 Centrifuge #368 | in-calibration | 2025-04-10 | qualified |
| AST-01368 Lyophilizer #369 | in-maintenance | 2026-10-03 | requalification-due |
| AST-01369 Filling Machine #370 | out-of-service | 2025-09-02 | not-qualified |
| AST-01370 Visual Inspection System #371 | cleaning-required | 2025-04-13 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | major | under-review | Not linked |
| Material Discrepancy | major | under-review | Not linked |
| Material Discrepancy | major | under-review | Not linked |
| Material Discrepancy | major | under-review | Not linked |
| Material Discrepancy | major | under-review | Not linked |
| Material Discrepancy | major | under-review | Not linked |
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-020452
Score: 94
EBR completionComplete
Exceptions closedOpen
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.