Batch BT-020397
Torvamab Lite • PPL • L048 • 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
2025-06-23 → 2025-06-26
Actual
2026-04-10 → In progress
Exceptions
25
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010176 | Methanol HPLC Grade Variant 5 | rejected | Open workbench |
| LOT-010177 | Hydrochloric Acid 37% Variant 5 | expired | Open workbench |
| LOT-010178 | Sodium Hydroxide Variant 5 | consumed | Open workbench |
| LOT-010179 | Phosphoric Acid Variant 5 | in-process | Open workbench |
| LOT-010180 | Active Pharmaceutical Ingredient A Variant 6 | approved | Open workbench |
| LOT-010181 | Active Pharmaceutical Ingredient B Variant 6 | approved | Open workbench |
| LOT-010182 | Active Pharmaceutical Ingredient C Variant 6 | approved | Open workbench |
| LOT-010183 | Microcrystalline Cellulose Variant 6 | quarantine | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01388 Incubator #389 | in-calibration | 2026-07-07 | requalification-due |
| AST-01389 Autoclave Sterilizer #390 | in-maintenance | 2025-05-21 | not-qualified |
| AST-01390 Conveyor Belt #391 | out-of-service | 2025-10-24 | qualified |
| AST-01391 Labeling Machine #392 | cleaning-required | 2025-10-16 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | minor | under-review | dev-00398 |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | dev-00898 |
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-020397
Score: 61
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.