Batch BT-020358
Serathide • CMO1 • 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
2025-12-21 → 2025-12-28
Actual
2025-04-06 → 2025-02-22
Exceptions
12
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012506 | Sucrose Variant 3 | hold | Open workbench |
| LOT-012507 | Trehalose Variant 3 | rejected | Open workbench |
| LOT-012508 | Histidine Buffer Variant 3 | expired | Open workbench |
| LOT-012509 | Sodium Chloride Variant 3 | consumed | Open workbench |
| LOT-012510 | Water for Injection Variant 3 | in-process | Open workbench |
| LOT-012511 | Purified Water Variant 3 | approved | Open workbench |
| LOT-012512 | Ethanol 95% Variant 3 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01148 Incubator #149 | operational | 2025-04-28 | requalification-due |
| AST-01149 Autoclave Sterilizer #150 | operational | 2025-12-13 | not-qualified |
| AST-01150 Conveyor Belt #151 | in-calibration | 2025-01-02 | qualified |
| AST-01151 Labeling Machine #152 | in-maintenance | 2026-07-06 | qualified |
| AST-01152 Cartoning Machine #153 | out-of-service | 2025-12-14 | qualified |
| AST-01153 Blister Packer #154 | cleaning-required | 2024-08-19 | 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-020358
Score: 93
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.