Batch BT-020577
Torvamab Lite • DRH • 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
2025-07-16 → 2025-07-25
Actual
2024-02-01 → In progress
Exceptions
24
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011039 | Sodium Chloride Variant 4 | hold | Open workbench |
| LOT-011040 | Water for Injection Variant 4 | rejected | Open workbench |
| LOT-011041 | Purified Water Variant 4 | expired | Open workbench |
| LOT-011042 | Ethanol 95% Variant 4 | consumed | Open workbench |
| LOT-011043 | Isopropyl Alcohol Variant 4 | in-process | Open workbench |
| LOT-011044 | Methylene Chloride Variant 4 | approved | Open workbench |
| LOT-011045 | Acetonitrile HPLC Grade Variant 4 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01262 WFI Still #263 | in-calibration | 2025-12-30 | qualified |
| AST-01263 RO System #264 | in-maintenance | 2025-10-05 | requalification-due |
| AST-01264 Compressed Air System #265 | out-of-service | 2025-03-24 | not-qualified |
| AST-01265 HVAC Unit #266 | cleaning-required | 2024-12-12 | qualified |
| AST-01266 Refrigerator #267 | operational | 2025-01-08 | qualified |
| AST-01267 Freezer Ultra-Low #268 | operational | 2026-04-07 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | dev-00078 |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | dev-00078 |
| 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.
No release readiness record found.