Batch BT-020378
Eptiveron HD • BSL • L029 • rejected
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
2024-12-06 → 2024-12-17
Actual
2024-08-01 → 2024-07-03
Exceptions
4
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010402 | Titanium Dioxide Variant 3 | expired | Open workbench |
| LOT-010403 | Polyethylene Glycol 400 Variant 3 | consumed | Open workbench |
| LOT-010404 | Polysorbate 80 Variant 3 | in-process | Open workbench |
| LOT-010405 | Mannitol Variant 3 | approved | Open workbench |
| LOT-010406 | Sucrose Variant 3 | approved | Open workbench |
| LOT-010407 | Trehalose Variant 3 | approved | Open workbench |
| LOT-010408 | Histidine Buffer Variant 3 | quarantine | Open workbench |
| LOT-010409 | Sodium Chloride Variant 3 | hold | Open workbench |
| LOT-010410 | Water for Injection Variant 3 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01268 Incubator #269 | operational | 2025-03-08 | requalification-due |
| AST-01269 Autoclave Sterilizer #270 | in-calibration | 2025-12-25 | not-qualified |
| AST-01270 Conveyor Belt #271 | in-maintenance | 2026-08-30 | qualified |
| 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 |
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-020378
Score: 92
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedOpen
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.