Batch BT-020357
Mentreva • PPL • 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
2025-09-04 → 2025-09-12
Actual
2024-01-09 → In progress
Exceptions
16
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011785 | Mannitol Variant 9 | quarantine | Open workbench |
| LOT-011786 | Sucrose Variant 9 | hold | Open workbench |
| LOT-011787 | Trehalose Variant 9 | rejected | Open workbench |
| LOT-011788 | Histidine Buffer Variant 9 | expired | Open workbench |
| LOT-011789 | Sodium Chloride Variant 9 | consumed | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01142 WFI Still #143 | operational | 2026-05-24 | qualified |
| AST-01143 RO System #144 | in-calibration | 2024-12-26 | requalification-due |
| AST-01144 Compressed Air System #145 | in-maintenance | 2026-08-24 | not-qualified |
| AST-01145 HVAC Unit #146 | out-of-service | 2025-04-06 | qualified |
| AST-01146 Refrigerator #147 | cleaning-required | 2025-06-15 | qualified |
| AST-01147 Freezer Ultra-Low #148 | operational | 2025-02-07 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | minor | under-review | dev-00358 |
| Environmental Excursion | minor | under-review | dev-01358 |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | dev-01358 |
| Environmental Excursion | minor | under-review | dev-00858 |
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-020357
Score: 95
EBR completionOpen
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedOpen
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.