Batch BT-020408
Eptiveron HD • NWK • L009 • 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
2024-12-28 → 2025-01-11
Actual
2026-01-24 → 2025-12-05
Exceptions
14
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010672 | Titanium Dioxide Variant 2 | expired | Open workbench |
| LOT-010673 | Polyethylene Glycol 400 Variant 2 | consumed | Open workbench |
| LOT-010674 | Polysorbate 80 Variant 2 | in-process | Open workbench |
| LOT-010675 | Mannitol Variant 2 | approved | Open workbench |
| LOT-010676 | Sucrose Variant 2 | approved | Open workbench |
| LOT-010677 | Trehalose Variant 2 | approved | Open workbench |
| LOT-010678 | Histidine Buffer Variant 2 | quarantine | Open workbench |
| LOT-010679 | Sodium Chloride Variant 2 | hold | Open workbench |
| LOT-010680 | Water for Injection Variant 2 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01056 Hardness Tester #57 | operational | 2026-03-10 | qualified |
| AST-01057 Friability Tester #58 | operational | 2024-12-14 | qualified |
| AST-01058 Particle Size Analyzer #59 | operational | 2025-08-28 | requalification-due |
| AST-01059 Microscope #60 | in-calibration | 2024-04-13 | not-qualified |
| AST-01060 Laminar Flow Cabinet #61 | in-maintenance | 2026-07-24 | qualified |
| AST-01061 Isolator #62 | out-of-service | 2024-10-01 | qualified |
| AST-01062 WFI Still #63 | cleaning-required | 2025-11-03 | 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-020408
Score: 66
EBR completionComplete
Exceptions closedOpen
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.