Batch BT-020607
Torvamab Lite • CMO2 • L008 • 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
2024-10-21 → 2024-10-29
Actual
2026-09-02 → In progress
Exceptions
22
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011856 | Methanol HPLC Grade Variant 1 | approved | Open workbench |
| LOT-011857 | Hydrochloric Acid 37% Variant 1 | quarantine | Open workbench |
| LOT-011858 | Sodium Hydroxide Variant 1 | hold | Open workbench |
| LOT-011859 | Phosphoric Acid Variant 1 | rejected | Open workbench |
| LOT-011860 | Active Pharmaceutical Ingredient A Variant 2 | expired | Open workbench |
| LOT-011861 | Active Pharmaceutical Ingredient B Variant 2 | consumed | Open workbench |
| LOT-011862 | Active Pharmaceutical Ingredient C Variant 2 | in-process | Open workbench |
| LOT-011863 | Microcrystalline Cellulose Variant 2 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01042 Film Coater #43 | operational | 2024-05-23 | qualified |
| AST-01043 Capsule Filler #44 | operational | 2026-01-03 | requalification-due |
| AST-01044 Blender #45 | operational | 2025-10-02 | not-qualified |
| AST-01045 Autoclave #46 | in-calibration | 2025-10-23 | qualified |
| AST-01046 Bioreactor #47 | in-maintenance | 2025-07-26 | qualified |
| AST-01047 Centrifuge #48 | out-of-service | 2026-01-16 | 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 | Not linked |
| System Error | minor | under-review | Not linked |
| System Error | minor | under-review | dev-00608 |
| 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.
No release readiness record found.