Batch BT-020334
Bioxalin • CMO1 • L035 • released
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
2025-11-09 → 2025-11-21
Actual
2024-01-26 → 2025-12-24
Exceptions
15
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011670 | Water for Injection Variant 5 | rejected | Open workbench |
| LOT-011671 | Purified Water Variant 5 | expired | Open workbench |
| LOT-011672 | Ethanol 95% Variant 5 | consumed | Open workbench |
| LOT-011673 | Isopropyl Alcohol Variant 5 | in-process | Open workbench |
| LOT-011674 | Methylene Chloride Variant 5 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01136 Hardness Tester #137 | in-calibration | 2025-03-19 | qualified |
| AST-01137 Friability Tester #138 | in-maintenance | 2025-06-23 | qualified |
| AST-01138 Particle Size Analyzer #139 | out-of-service | 2025-07-11 | requalification-due |
| AST-01139 Microscope #140 | cleaning-required | 2025-01-16 | not-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-020334
Score: 67
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.