Batch BT-020337
Torvamab Lite • DRH • L038 • 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
2024-02-10 → 2024-02-16
Actual
2025-12-15 → In progress
Exceptions
24
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011685 | Hydroxypropyl Methylcellulose Variant 6 | approved | Open workbench |
| LOT-011686 | Magnesium Stearate Variant 6 | quarantine | Open workbench |
| LOT-011687 | Croscarmellose Sodium Variant 6 | hold | Open workbench |
| LOT-011688 | Povidone K30 Variant 6 | rejected | Open workbench |
| LOT-011689 | Talc Variant 6 | expired | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01022 WFI Still #23 | operational | 2025-10-20 | qualified |
| AST-01023 RO System #24 | operational | 2024-12-20 | requalification-due |
| AST-01024 Compressed Air System #25 | in-calibration | 2025-01-26 | not-qualified |
| AST-01025 HVAC Unit #26 | in-maintenance | 2026-03-31 | qualified |
| AST-01026 Refrigerator #27 | out-of-service | 2026-03-19 | qualified |
| AST-01027 Freezer Ultra-Low #28 | cleaning-required | 2025-07-06 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | minor | under-review | dev-00338 |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | dev-01338 |
| Missing Signature | 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-020337
Score: 82
EBR completionComplete
Exceptions closedOpen
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.