Batch BT-020153
Celdurin IV • DRH • L004 • 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
2026-03-22 → 2026-03-26
Actual
2026-05-19 → 2024-12-15
Exceptions
13
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 |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01271 Labeling Machine #272 | out-of-service | 2025-08-17 | qualified |
| AST-01272 Cartoning Machine #273 | cleaning-required | 2025-03-02 | qualified |
| AST-01273 Blister Packer #274 | operational | 2025-05-24 | requalification-due |
| AST-01274 Shrink Wrapper #275 | operational | 2025-10-04 | not-qualified |
| AST-01275 Checkweigher #276 | operational | 2025-10-02 | qualified |
| AST-01276 Metal Detector #277 | in-calibration | 2026-09-04 | qualified |
| AST-01277 X-Ray Inspection #278 | in-maintenance | 2026-03-25 | 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.
Release Readiness: BT-020153
Score: 88
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.