Batch BT-020336
Torvamab • NWK • L037 • released
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
2026-09-24 → 2026-09-28
Actual
2026-12-18 → 2025-11-27
Exceptions
4
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010360 | Active Pharmaceutical Ingredient A Variant 2 | approved | Open workbench |
| LOT-010361 | Active Pharmaceutical Ingredient B Variant 2 | approved | Open workbench |
| LOT-010362 | Active Pharmaceutical Ingredient C Variant 2 | approved | Open workbench |
| LOT-010363 | Microcrystalline Cellulose Variant 2 | quarantine | Open workbench |
| LOT-010364 | Lactose Monohydrate Variant 2 | hold | Open workbench |
| LOT-010365 | Hydroxypropyl Methylcellulose Variant 2 | rejected | Open workbench |
| LOT-010366 | Magnesium Stearate Variant 2 | expired | Open workbench |
| LOT-010367 | Croscarmellose Sodium Variant 2 | consumed | Open workbench |
| LOT-010368 | Povidone K30 Variant 2 | in-process | Open workbench |
| LOT-010369 | Talc Variant 2 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01288 Lyophilizer #289 | operational | 2026-01-06 | requalification-due |
| AST-01289 Filling Machine #290 | operational | 2026-10-06 | not-qualified |
| AST-01290 Visual Inspection System #291 | in-calibration | 2025-07-30 | qualified |
| AST-01291 Weighing Balance #292 | in-maintenance | 2026-05-11 | qualified |
| AST-01292 HPLC System #293 | out-of-service | 2024-08-18 | qualified |
| AST-01293 UV-Vis Spectrophotometer #294 | cleaning-required | 2025-09-10 | requalification-due |
| AST-01294 Karl Fischer Titrator #295 | operational | 2024-11-01 | not-qualified |
| AST-01295 Dissolution Tester #296 | operational | 2025-04-03 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Out of Specification | minor | under-review | Not linked |
| Out of Specification | minor | under-review | Not linked |
| Out of Specification | minor | under-review | Not linked |
| Out of Specification | minor | under-review | dev-00337 |
| Out of Specification | minor | under-review | Not linked |
| Out of Specification | minor | under-review | dev-00837 |
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-020336
Score: 100
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.