Batch BT-020157
Torvamab Lite • PPL • L008 • 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
2026-08-18 → 2026-08-22
Actual
2025-02-11 → In progress
Exceptions
22
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011413 | Microcrystalline Cellulose Variant 7 | approved | Open workbench |
| LOT-011414 | Lactose Monohydrate Variant 7 | approved | Open workbench |
| LOT-011415 | Hydroxypropyl Methylcellulose Variant 7 | approved | Open workbench |
| LOT-011416 | Magnesium Stearate Variant 7 | quarantine | Open workbench |
| LOT-011417 | Croscarmellose Sodium Variant 7 | hold | Open workbench |
| LOT-011418 | Povidone K30 Variant 7 | rejected | Open workbench |
| LOT-011419 | Talc Variant 7 | expired | Open workbench |
| LOT-011420 | Colloidal Silicon Dioxide Variant 7 | consumed | Open workbench |
| LOT-011421 | Stearic Acid Variant 7 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01056 Hardness Tester #57 | operational | 2026-03-10 | qualified |
| AST-01057 Friability Tester #58 | operational | 2024-12-14 | qualified |
| AST-01058 Particle Size Analyzer #59 | operational | 2025-08-28 | requalification-due |
| AST-01059 Microscope #60 | in-calibration | 2024-04-13 | not-qualified |
| AST-01060 Laminar Flow Cabinet #61 | in-maintenance | 2026-07-24 | qualified |
| AST-01061 Isolator #62 | out-of-service | 2024-10-01 | qualified |
| AST-01062 WFI Still #63 | cleaning-required | 2025-11-03 | qualified |
| AST-01063 RO System #64 | operational | 2025-04-21 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | dev-01158 |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | dev-00158 |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | 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-020157
Score: 87
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
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.