Batch BT-020550
Nexipar • CMO1 • L001 • 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
2025-06-22 → 2025-07-02
Actual
2025-05-26 → In progress
Exceptions
9
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010300 | Active Pharmaceutical Ingredient A | quarantine | Open workbench |
| LOT-010301 | Active Pharmaceutical Ingredient B | hold | Open workbench |
| LOT-010302 | Active Pharmaceutical Ingredient C | rejected | Open workbench |
| LOT-010303 | Microcrystalline Cellulose | expired | Open workbench |
| LOT-010304 | Lactose Monohydrate | consumed | Open workbench |
| LOT-010305 | Hydroxypropyl Methylcellulose | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01250 Visual Inspection System #251 | out-of-service | 2026-04-25 | qualified |
| AST-01251 Weighing Balance #252 | cleaning-required | 2025-07-12 | qualified |
| AST-01252 HPLC System #253 | operational | 2025-08-30 | qualified |
| AST-01253 UV-Vis Spectrophotometer #254 | operational | 2025-03-08 | requalification-due |
| AST-01254 Karl Fischer Titrator #255 | operational | 2025-02-12 | not-qualified |
| AST-01255 Dissolution Tester #256 | in-calibration | 2026-02-15 | qualified |
| AST-01256 Hardness Tester #257 | in-maintenance | 2025-07-11 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | dev-00051 |
| 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.