Batch BT-020507
Mentreva • SGP • L008 • on-hold
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
2025-11-19 → 2025-12-03
Actual
2025-12-04 → In progress
Exceptions
19
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012535 | Mannitol Variant 4 | expired | Open workbench |
| LOT-012536 | Sucrose Variant 4 | consumed | Open workbench |
| LOT-012537 | Trehalose Variant 4 | in-process | Open workbench |
| LOT-012538 | Histidine Buffer Variant 4 | approved | Open workbench |
| LOT-012539 | Sodium Chloride Variant 4 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01135 Dissolution Tester #136 | operational | 2026-03-20 | qualified |
| AST-01136 Hardness Tester #137 | in-calibration | 2025-03-19 | qualified |
| AST-01137 Friability Tester #138 | in-maintenance | 2025-06-23 | qualified |
| AST-01138 Particle Size Analyzer #139 | out-of-service | 2025-07-11 | requalification-due |
| AST-01139 Microscope #140 | cleaning-required | 2025-01-16 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Equipment Conflict | minor | under-review | dev-00508 |
| Equipment Conflict | minor | under-review | Not linked |
| Equipment Conflict | minor | under-review | Not linked |
| Equipment Conflict | minor | under-review | Not linked |
| Equipment Conflict | minor | under-review | Not linked |
| Equipment Conflict | minor | under-review | dev-01008 |
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.