Batch BT-020911
Nexipar SR • CMO2 • L012 • 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
2026-09-18 → 2026-10-02
Actual
2026-10-19 → In progress
Exceptions
15
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010644 | Polysorbate 80 Variant 1 | rejected | Open workbench |
| LOT-010645 | Mannitol Variant 1 | expired | Open workbench |
| LOT-010646 | Sucrose Variant 1 | consumed | Open workbench |
| LOT-010647 | Trehalose Variant 1 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01088 Lyophilizer #89 | in-maintenance | 2026-09-09 | requalification-due |
| AST-01089 Filling Machine #90 | out-of-service | 2025-11-07 | not-qualified |
| AST-01090 Visual Inspection System #91 | cleaning-required | 2026-09-15 | qualified |
| AST-01091 Weighing Balance #92 | operational | 2025-10-14 | qualified |
| AST-01092 HPLC System #93 | operational | 2026-06-30 | qualified |
| AST-01093 UV-Vis Spectrophotometer #94 | operational | 2025-04-29 | requalification-due |
| AST-01094 Karl Fischer Titrator #95 | in-calibration | 2026-07-06 | not-qualified |
| AST-01095 Dissolution Tester #96 | in-maintenance | 2025-08-22 | 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-01412 |
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.