Batch BT-020387
Mentreva • SGP • L038 • 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
2024-03-28 → 2024-04-08
Actual
2026-08-21 → In progress
Exceptions
24
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011935 | Mannitol Variant 4 | approved | Open workbench |
| LOT-011936 | Sucrose Variant 4 | approved | Open workbench |
| LOT-011937 | Trehalose Variant 4 | approved | Open workbench |
| LOT-011938 | Histidine Buffer Variant 4 | quarantine | Open workbench |
| LOT-011939 | Sodium Chloride Variant 4 | hold | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01322 Film Coater #323 | operational | 2025-04-11 | qualified |
| AST-01323 Capsule Filler #324 | operational | 2025-10-01 | requalification-due |
| AST-01324 Blender #325 | operational | 2026-07-10 | not-qualified |
| AST-01325 Autoclave #326 | in-calibration | 2025-01-01 | qualified |
| AST-01326 Bioreactor #327 | in-maintenance | 2026-01-21 | qualified |
| AST-01327 Centrifuge #328 | out-of-service | 2025-04-18 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| 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-01388 |
| Equipment Conflict | 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.
Release Readiness: BT-020387
Score: 69
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.