Batch BT-020516
Torvamab • DUB • 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
2024-02-05 → 2024-02-18
Actual
2026-04-09 → 2026-09-29
Exceptions
9
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011548 | Histidine Buffer Variant 1 | approved | Open workbench |
| LOT-011549 | Sodium Chloride Variant 1 | approved | Open workbench |
| LOT-011550 | Water for Injection Variant 1 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01128 Lyophilizer #129 | operational | 2025-07-24 | requalification-due |
| AST-01129 Filling Machine #130 | in-calibration | 2025-02-21 | not-qualified |
| AST-01130 Visual Inspection System #131 | in-maintenance | 2025-09-14 | qualified |
| AST-01131 Weighing Balance #132 | out-of-service | 2026-02-22 | qualified |
| AST-01132 HPLC System #133 | cleaning-required | 2026-03-27 | qualified |
| AST-01133 UV-Vis Spectrophotometer #134 | operational | 2026-05-23 | requalification-due |
| AST-01134 Karl Fischer Titrator #135 | operational | 2025-06-28 | not-qualified |
| AST-01135 Dissolution Tester #136 | operational | 2026-03-20 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | minor | under-review | dev-00517 |
| Material Discrepancy | minor | under-review | Not linked |
| Material Discrepancy | minor | under-review | Not linked |
| Material Discrepancy | minor | under-review | Not linked |
| Material Discrepancy | minor | under-review | Not linked |
| Material Discrepancy | 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.