Batch BT-020451
Veranide XR • SGP • L002 • 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
2024-12-11 → 2024-12-20
Actual
2025-08-30 → In progress
Exceptions
21
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011510 | Colloidal Silicon Dioxide | consumed | Open workbench |
| LOT-011511 | Stearic Acid | in-process | Open workbench |
| LOT-011512 | Titanium Dioxide | approved | Open workbench |
| LOT-011513 | Polyethylene Glycol 400 | approved | Open workbench |
| LOT-011514 | Polysorbate 80 | approved | Open workbench |
| LOT-011515 | Mannitol | quarantine | Open workbench |
| LOT-011516 | Sucrose | hold | Open workbench |
| LOT-011517 | Trehalose | rejected | Open workbench |
| LOT-011518 | Histidine Buffer | expired | Open workbench |
| LOT-011519 | Sodium Chloride | consumed | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01255 Dissolution Tester #256 | in-calibration | 2026-02-15 | qualified |
| AST-01256 Hardness Tester #257 | in-maintenance | 2025-07-11 | qualified |
| AST-01257 Friability Tester #258 | out-of-service | 2026-10-02 | qualified |
| AST-01258 Particle Size Analyzer #259 | cleaning-required | 2026-10-10 | requalification-due |
| AST-01259 Microscope #260 | operational | 2026-08-31 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Equipment Conflict | major | under-review | dev-00452 |
| Equipment Conflict | major | under-review | Not linked |
| Equipment Conflict | major | under-review | dev-00952 |
| Equipment Conflict | major | under-review | Not linked |
| Equipment Conflict | major | under-review | dev-01452 |
| Equipment Conflict | major | under-review | dev-00952 |
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-020451
Score: 89
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
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.