Batch BT-020670
Nexipar • CMO1 • L021 • 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
2026-09-29 → 2026-10-13
Actual
2026-11-05 → In progress
Exceptions
25
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011020 | Active Pharmaceutical Ingredient A Variant 4 | quarantine | Open workbench |
| LOT-011021 | Active Pharmaceutical Ingredient B Variant 4 | hold | Open workbench |
| LOT-011022 | Active Pharmaceutical Ingredient C Variant 4 | rejected | Open workbench |
| LOT-011023 | Microcrystalline Cellulose Variant 4 | expired | Open workbench |
| LOT-011024 | Lactose Monohydrate Variant 4 | consumed | Open workbench |
| LOT-011025 | Hydroxypropyl Methylcellulose Variant 4 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01290 Visual Inspection System #291 | in-calibration | 2025-07-30 | qualified |
| AST-01291 Weighing Balance #292 | in-maintenance | 2026-05-11 | qualified |
| AST-01292 HPLC System #293 | out-of-service | 2024-08-18 | qualified |
| AST-01293 UV-Vis Spectrophotometer #294 | cleaning-required | 2025-09-10 | requalification-due |
| AST-01294 Karl Fischer Titrator #295 | operational | 2024-11-01 | not-qualified |
| AST-01295 Dissolution Tester #296 | operational | 2025-04-03 | qualified |
| AST-01296 Hardness Tester #297 | operational | 2025-06-03 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | critical | open | dev-00671 |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | dev-01171 |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | 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.