Batch BT-020365
Bioxalin SC • PPL • L016 • 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
2025-06-19 → 2025-06-22
Actual
2025-11-13 → 2026-11-02
Exceptions
19
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011095 | Mannitol Variant 6 | expired | Open workbench |
| LOT-011096 | Sucrose Variant 6 | consumed | Open workbench |
| LOT-011097 | Trehalose Variant 6 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01120 Granulator #121 | operational | 2024-11-05 | qualified |
| AST-01121 Tablet Press #122 | operational | 2026-06-17 | qualified |
| AST-01122 Film Coater #123 | in-calibration | 2025-03-07 | qualified |
| AST-01123 Capsule Filler #124 | in-maintenance | 2025-01-24 | requalification-due |
| AST-01124 Blender #125 | out-of-service | 2025-08-21 | not-qualified |
| AST-01125 Autoclave #126 | cleaning-required | 2025-10-08 | qualified |
| AST-01126 Bioreactor #127 | operational | 2026-01-30 | qualified |
| AST-01127 Centrifuge #128 | operational | 2026-02-27 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | minor | open | Not linked |
| Environmental Excursion | minor | open | Not linked |
| Environmental Excursion | minor | open | dev-00866 |
| Environmental Excursion | minor | open | Not linked |
| Environmental Excursion | minor | open | Not linked |
| Environmental Excursion | minor | open | Not linked |
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-020365
Score: 83
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedOpen
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.