Batch BT-020247
Torvamab Lite • CMO2 • L048 • 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
2024-12-06 → 2024-12-15
Actual
2026-06-14 → In progress
Exceptions
1
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012223 | Microcrystalline Cellulose Variant 4 | approved | Open workbench |
| LOT-012224 | Lactose Monohydrate Variant 4 | approved | Open workbench |
| LOT-012225 | Hydroxypropyl Methylcellulose Variant 4 | approved | Open workbench |
| LOT-012226 | Magnesium Stearate Variant 4 | quarantine | Open workbench |
| LOT-012227 | Croscarmellose Sodium Variant 4 | hold | Open workbench |
| LOT-012228 | Povidone K30 Variant 4 | rejected | Open workbench |
| LOT-012229 | Talc Variant 4 | expired | Open workbench |
| LOT-012230 | Colloidal Silicon Dioxide Variant 4 | consumed | Open workbench |
| LOT-012231 | Stearic Acid Variant 4 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01376 Hardness Tester #377 | out-of-service | 2026-09-13 | qualified |
| AST-01377 Friability Tester #378 | cleaning-required | 2025-09-10 | qualified |
| AST-01378 Particle Size Analyzer #379 | operational | 2024-07-06 | requalification-due |
| AST-01379 Microscope #380 | operational | 2025-05-06 | not-qualified |
| AST-01380 Laminar Flow Cabinet #381 | operational | 2024-09-07 | qualified |
| AST-01381 Isolator #382 | in-calibration | 2026-05-05 | qualified |
| AST-01382 WFI Still #383 | in-maintenance | 2024-08-18 | qualified |
| AST-01383 RO System #384 | out-of-service | 2025-04-03 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
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-020247
Score: 68
EBR completionOpen
Exceptions closedOpen
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.