Batch BT-020367
Torvamab Lite • CMO2 • L018 • 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
2025-03-21 → 2025-04-01
Actual
2024-03-01 → In progress
Exceptions
14
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012936 | Methanol HPLC Grade Variant 7 | approved | Open workbench |
| LOT-012937 | Hydrochloric Acid 37% Variant 7 | quarantine | Open workbench |
| LOT-012938 | Sodium Hydroxide Variant 7 | hold | Open workbench |
| LOT-012939 | Phosphoric Acid Variant 7 | rejected | Open workbench |
| LOT-012940 | Active Pharmaceutical Ingredient A Variant 8 | expired | Open workbench |
| LOT-012941 | Active Pharmaceutical Ingredient B Variant 8 | consumed | Open workbench |
| LOT-012942 | Active Pharmaceutical Ingredient C Variant 8 | in-process | Open workbench |
| LOT-012943 | Microcrystalline Cellulose Variant 8 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01169 Filling Machine #170 | operational | 2026-04-30 | not-qualified |
| AST-01170 Visual Inspection System #171 | operational | 2025-02-18 | qualified |
| AST-01171 Weighing Balance #172 | in-calibration | 2025-05-11 | qualified |
| AST-01172 HPLC System #173 | in-maintenance | 2026-03-24 | qualified |
| AST-01173 UV-Vis Spectrophotometer #174 | out-of-service | 2024-07-28 | requalification-due |
| AST-01174 Karl Fischer Titrator #175 | cleaning-required | 2025-12-31 | not-qualified |
| AST-01175 Dissolution Tester #176 | operational | 2024-11-26 | qualified |
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-020367
Score: 94
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
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.