Batch BT-020366
Torvamab • CMO1 • L017 • 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
2025-08-05 → 2025-08-19
Actual
2026-11-24 → 2026-12-11
Exceptions
24
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012562 | Titanium Dioxide Variant 5 | expired | Open workbench |
| LOT-012563 | Polyethylene Glycol 400 Variant 5 | consumed | Open workbench |
| LOT-012564 | Polysorbate 80 Variant 5 | in-process | Open workbench |
| LOT-012565 | Mannitol Variant 5 | approved | Open workbench |
| LOT-012566 | Sucrose Variant 5 | approved | Open workbench |
| LOT-012567 | Trehalose Variant 5 | approved | Open workbench |
| LOT-012568 | Histidine Buffer Variant 5 | quarantine | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01162 Film Coater #163 | operational | 2025-10-05 | qualified |
| AST-01163 Capsule Filler #164 | operational | 2025-01-25 | requalification-due |
| AST-01164 Blender #165 | in-calibration | 2025-09-18 | not-qualified |
| AST-01165 Autoclave #166 | in-maintenance | 2025-08-05 | qualified |
| AST-01166 Bioreactor #167 | out-of-service | 2025-07-30 | qualified |
| AST-01167 Centrifuge #168 | cleaning-required | 2024-12-24 | qualified |
| AST-01168 Lyophilizer #169 | operational | 2024-06-02 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | minor | under-review | dev-00367 |
| Procedure Deviation | minor | under-review | Not linked |
| Procedure Deviation | minor | under-review | Not linked |
| Procedure Deviation | minor | under-review | Not linked |
| Procedure Deviation | minor | under-review | Not linked |
| Procedure Deviation | 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-020366
Score: 90
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.