Batch BT-020701
Nexipar SR • PPL • L002 • 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
2024-08-11 → 2024-08-24
Actual
2025-02-26 → In progress
Exceptions
24
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012103 | Microcrystalline Cellulose | expired | Open workbench |
| LOT-012104 | Lactose Monohydrate | consumed | Open workbench |
| LOT-012105 | Hydroxypropyl Methylcellulose | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01008 Lyophilizer #9 | operational | 2026-08-12 | requalification-due |
| AST-01009 Filling Machine #10 | operational | 2026-08-10 | not-qualified |
| AST-01010 Visual Inspection System #11 | in-calibration | 2025-05-23 | qualified |
| AST-01011 Weighing Balance #12 | in-maintenance | 2026-05-08 | qualified |
| AST-01012 HPLC System #13 | out-of-service | 2025-02-09 | qualified |
| AST-01013 UV-Vis Spectrophotometer #14 | cleaning-required | 2025-08-09 | requalification-due |
| AST-01014 Karl Fischer Titrator #15 | operational | 2025-01-06 | not-qualified |
| AST-01015 Dissolution Tester #16 | operational | 2026-09-05 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | major | under-review | dev-00702 |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | 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.