Batch BT-020597
Mentreva • PPL • L048 • 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
2026-03-07 → 2026-03-11
Actual
2025-05-25 → In progress
Exceptions
20
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012985 | Mannitol Variant 9 | expired | Open workbench |
| LOT-012986 | Sucrose Variant 9 | consumed | Open workbench |
| LOT-012987 | Trehalose Variant 9 | in-process | Open workbench |
| LOT-012988 | Histidine Buffer Variant 9 | approved | Open workbench |
| LOT-012989 | Sodium Chloride Variant 9 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01376 Hardness Tester #377 | out-of-service | 2026-09-13 | qualified |
| AST-01377 Friability Tester #378 | cleaning-required | 2025-09-10 | qualified |
| AST-01378 Particle Size Analyzer #379 | operational | 2024-07-06 | requalification-due |
| AST-01379 Microscope #380 | operational | 2025-05-06 | not-qualified |
| AST-01380 Laminar Flow Cabinet #381 | operational | 2024-09-07 | qualified |
| AST-01381 Isolator #382 | in-calibration | 2026-05-05 | qualified |
| AST-01382 WFI Still #383 | in-maintenance | 2024-08-18 | qualified |
| AST-01383 RO System #384 | out-of-service | 2025-04-03 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | 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.