Batch BT-020298
Serathide • BSL • L049 • 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
2024-07-27 → 2024-08-06
Actual
2024-05-23 → 2024-12-05
Exceptions
16
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012086 | Sucrose Variant 9 | consumed | Open workbench |
| LOT-012087 | Trehalose Variant 9 | in-process | Open workbench |
| LOT-012088 | Histidine Buffer Variant 9 | approved | Open workbench |
| LOT-012089 | Sodium Chloride Variant 9 | approved | Open workbench |
| LOT-012090 | Water for Injection Variant 9 | approved | Open workbench |
| LOT-012091 | Purified Water Variant 9 | quarantine | Open workbench |
| LOT-012092 | Ethanol 95% Variant 9 | hold | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01086 Bioreactor #87 | operational | 2024-09-24 | qualified |
| AST-01087 Centrifuge #88 | in-calibration | 2026-06-09 | qualified |
| AST-01088 Lyophilizer #89 | in-maintenance | 2026-09-09 | requalification-due |
| AST-01089 Filling Machine #90 | out-of-service | 2025-11-07 | not-qualified |
| AST-01090 Visual Inspection System #91 | cleaning-required | 2026-09-15 | qualified |
| AST-01091 Weighing Balance #92 | operational | 2025-10-14 | qualified |
| AST-01092 HPLC System #93 | operational | 2026-06-30 | 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-020298
Score: 67
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
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.