Batch BT-020671
Nexipar SR • CMO2 • L022 • in-process
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
2024-04-17 → 2024-04-22
Actual
2026-09-05 → In progress
Exceptions
20
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010039 | Talc Variant 1 | quarantine | Open workbench |
| LOT-010040 | Colloidal Silicon Dioxide Variant 1 | hold | Open workbench |
| LOT-010041 | Stearic Acid Variant 1 | rejected | Open workbench |
| LOT-010042 | Titanium Dioxide Variant 1 | expired | Open workbench |
| LOT-010043 | Polyethylene Glycol 400 Variant 1 | consumed | Open workbench |
| LOT-010044 | Polysorbate 80 Variant 1 | in-process | Open workbench |
| LOT-010045 | Mannitol Variant 1 | approved | Open workbench |
| LOT-010046 | Sucrose Variant 1 | approved | Open workbench |
| LOT-010047 | Trehalose Variant 1 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01284 Blender #285 | in-maintenance | 2026-12-02 | not-qualified |
| AST-01285 Autoclave #286 | out-of-service | 2026-03-02 | qualified |
| AST-01286 Bioreactor #287 | cleaning-required | 2025-09-30 | qualified |
| AST-01287 Centrifuge #288 | operational | 2025-05-15 | 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.
No release readiness record found.