Batch BT-020753
Celdurin IV • DRH • L004 • completed
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
2026-03-15 → 2026-03-29
Actual
2024-05-23 → 2024-09-22
Exceptions
1
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010024 | Methylene Chloride | expired | Open workbench |
| LOT-010025 | Acetonitrile HPLC Grade | consumed | Open workbench |
| LOT-010026 | Methanol HPLC Grade | in-process | Open workbench |
| LOT-010027 | Hydrochloric Acid 37% | approved | Open workbench |
| LOT-010028 | Sodium Hydroxide | approved | Open workbench |
| LOT-010029 | Phosphoric Acid | approved | Open workbench |
| LOT-010030 | Active Pharmaceutical Ingredient A Variant 1 | quarantine | Open workbench |
| LOT-010031 | Active Pharmaceutical Ingredient B Variant 1 | hold | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01071 Labeling Machine #72 | operational | 2025-07-27 | qualified |
| AST-01072 Cartoning Machine #73 | operational | 2024-10-01 | qualified |
| AST-01073 Blister Packer #74 | in-calibration | 2024-11-11 | requalification-due |
| AST-01074 Shrink Wrapper #75 | in-maintenance | 2026-01-18 | not-qualified |
| AST-01075 Checkweigher #76 | out-of-service | 2026-09-09 | qualified |
| AST-01076 Metal Detector #77 | cleaning-required | 2024-05-27 | qualified |
| AST-01077 X-Ray Inspection #78 | operational | 2026-03-10 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
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.