Batch BT-020127
Torvamab Lite • CMO2 • L028 • 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
2025-11-20 → 2025-12-02
Actual
2024-10-15 → In progress
Exceptions
5
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010635 | Hydroxypropyl Methylcellulose Variant 1 | rejected | Open workbench |
| LOT-010636 | Magnesium Stearate Variant 1 | expired | Open workbench |
| LOT-010637 | Croscarmellose Sodium Variant 1 | consumed | Open workbench |
| LOT-010638 | Povidone K30 Variant 1 | in-process | Open workbench |
| LOT-010639 | Talc Variant 1 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01089 Filling Machine #90 | out-of-service | 2025-11-07 | not-qualified |
| AST-01090 Visual Inspection System #91 | cleaning-required | 2026-09-15 | qualified |
| AST-01091 Weighing Balance #92 | operational | 2025-10-14 | qualified |
| AST-01092 HPLC System #93 | operational | 2026-06-30 | qualified |
| AST-01093 UV-Vis Spectrophotometer #94 | operational | 2025-04-29 | requalification-due |
| AST-01094 Karl Fischer Titrator #95 | in-calibration | 2026-07-06 | not-qualified |
| AST-01095 Dissolution Tester #96 | in-maintenance | 2025-08-22 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| System Error | minor | under-review | Not linked |
| System Error | minor | under-review | dev-01128 |
| System Error | minor | under-review | Not linked |
| System Error | minor | under-review | Not linked |
| System Error | minor | under-review | Not linked |
| System Error | 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-020127
Score: 99
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedOpen
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.