Batch BT-020704
Gastrivax • NWK • L005 • 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
2026-11-15 → 2026-11-24
Actual
2025-10-11 → 2024-12-07
Exceptions
11
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012112 | Titanium Dioxide | expired | Open workbench |
| LOT-012113 | Polyethylene Glycol 400 | consumed | Open workbench |
| LOT-012114 | Polysorbate 80 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01016 Hardness Tester #17 | operational | 2024-07-12 | qualified |
| AST-01017 Friability Tester #18 | in-calibration | 2025-04-30 | qualified |
| AST-01018 Particle Size Analyzer #19 | in-maintenance | 2025-09-18 | requalification-due |
| AST-01019 Microscope #20 | out-of-service | 2026-03-22 | 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.
No release readiness record found.