Batch BT-020276
Torvamab • DUB • L027 • 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
2026-10-01 → 2026-10-05
Actual
2026-08-11 → 2024-06-06
Exceptions
8
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010828 | Histidine Buffer Variant 7 | approved | Open workbench |
| LOT-010829 | Sodium Chloride Variant 7 | approved | Open workbench |
| LOT-010830 | Water for Injection Variant 7 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01028 Incubator #29 | operational | 2024-08-03 | requalification-due |
| AST-01029 Autoclave Sterilizer #30 | operational | 2024-11-19 | not-qualified |
| AST-01030 Conveyor Belt #31 | operational | 2026-04-11 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | minor | under-review | Not linked |
| Material Discrepancy | minor | under-review | dev-01277 |
| Material Discrepancy | minor | under-review | Not linked |
| Material Discrepancy | minor | under-review | dev-00277 |
| Material Discrepancy | minor | under-review | dev-01277 |
| Material Discrepancy | minor | under-review | dev-00777 |
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-020276
Score: 76
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.