Batch BT-020791
Nexipar SR • CMO2 • L042 • 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
2026-06-26 → 2026-07-06
Actual
2024-10-20 → In progress
Exceptions
5
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012373 | Microcrystalline Cellulose Variant 9 | expired | Open workbench |
| LOT-012374 | Lactose Monohydrate Variant 9 | consumed | Open workbench |
| LOT-012375 | Hydroxypropyl Methylcellulose Variant 9 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01364 Blender #365 | operational | 2025-04-05 | not-qualified |
| AST-01365 Autoclave #366 | operational | 2025-03-29 | qualified |
| AST-01366 Bioreactor #367 | operational | 2024-08-10 | qualified |
| AST-01367 Centrifuge #368 | in-calibration | 2025-04-10 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| System Error | major | under-review | Not linked |
| System Error | major | under-review | Not linked |
| System Error | major | under-review | Not linked |
| System Error | major | under-review | Not linked |
| System Error | major | under-review | Not linked |
| System Error | major | under-review | dev-01292 |
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.