Batch BT-020110
Neuraxin • CMO1 • L011 • in-process
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
2026-04-14 → 2026-04-22
Actual
2026-11-08 → In progress
Exceptions
4
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010880 | Colloidal Silicon Dioxide Variant 9 | consumed | Open workbench |
| LOT-010881 | Stearic Acid Variant 9 | in-process | Open workbench |
| LOT-010882 | Titanium Dioxide Variant 9 | approved | Open workbench |
| LOT-010883 | Polyethylene Glycol 400 Variant 9 | approved | Open workbench |
| LOT-010884 | Polysorbate 80 Variant 9 | approved | Open workbench |
| LOT-010885 | Mannitol Variant 9 | quarantine | Open workbench |
| LOT-010886 | Sucrose Variant 9 | hold | Open workbench |
| LOT-010887 | Trehalose Variant 9 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01370 Visual Inspection System #371 | cleaning-required | 2025-04-13 | qualified |
| AST-01371 Weighing Balance #372 | operational | 2025-10-07 | qualified |
| AST-01372 HPLC System #373 | operational | 2026-10-31 | qualified |
| AST-01373 UV-Vis Spectrophotometer #374 | operational | 2025-01-15 | requalification-due |
| AST-01374 Karl Fischer Titrator #375 | in-calibration | 2026-05-11 | not-qualified |
| AST-01375 Dissolution Tester #376 | in-maintenance | 2024-08-23 | qualified |
| AST-01376 Hardness Tester #377 | out-of-service | 2026-09-13 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | dev-01111 |
| Procedure Deviation | critical | 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-020110
Score: 85
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.