Batch BT-020788
Pulmozide • DUB • L039 • rejected
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
2026-02-02 → 2026-02-13
Actual
2026-04-24 → 2024-10-31
Exceptions
1
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010152 | Active Pharmaceutical Ingredient C Variant 5 | in-process | Open workbench |
| LOT-010153 | Microcrystalline Cellulose Variant 5 | approved | Open workbench |
| LOT-010154 | Lactose Monohydrate Variant 5 | approved | Open workbench |
| LOT-010155 | Hydroxypropyl Methylcellulose Variant 5 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01316 Metal Detector #317 | operational | 2026-01-11 | qualified |
| AST-01317 X-Ray Inspection #318 | operational | 2025-07-19 | qualified |
| AST-01318 Leak Tester #319 | in-calibration | 2026-02-08 | requalification-due |
| AST-01319 Torque Tester #320 | in-maintenance | 2026-03-01 | not-qualified |
| AST-01320 Granulator #321 | out-of-service | 2026-03-30 | qualified |
| AST-01321 Tablet Press #322 | cleaning-required | 2025-04-30 | qualified |
| AST-01322 Film Coater #323 | operational | 2025-04-11 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | 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.