Batch BT-020901
Veranide XR • PPL • 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
2026-12-22 → 2026-12-31
Actual
2026-11-22 → In progress
Exceptions
11
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012109 | Talc | quarantine | Open workbench |
| LOT-012110 | Colloidal Silicon Dioxide | hold | Open workbench |
| LOT-012111 | Stearic Acid | rejected | Open workbench |
| LOT-012112 | Titanium Dioxide | expired | Open workbench |
| LOT-012113 | Polyethylene Glycol 400 | consumed | Open workbench |
| LOT-012114 | Polysorbate 80 | in-process | Open workbench |
| LOT-012115 | Mannitol | approved | Open workbench |
| LOT-012116 | Sucrose | approved | Open workbench |
| LOT-012117 | Trehalose | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01303 RO System #304 | operational | 2026-05-07 | requalification-due |
| AST-01304 Compressed Air System #305 | in-calibration | 2026-05-29 | not-qualified |
| AST-01305 HVAC Unit #306 | in-maintenance | 2024-11-22 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | 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.
No release readiness record found.