Batch BT-020963
Celdurin IV • SGP • L014 • 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
2026-12-07 → 2026-12-14
Actual
2024-04-20 → 2026-06-06
Exceptions
5
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011815 | Mannitol | expired | Open workbench |
| LOT-011816 | Sucrose | consumed | Open workbench |
| LOT-011817 | Trehalose | in-process | Open workbench |
| LOT-011818 | Histidine Buffer | approved | Open workbench |
| LOT-011819 | Sodium Chloride | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| 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 |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Equipment Conflict | major | closed | dev-00964 |
| Equipment Conflict | major | closed | Not linked |
| Equipment Conflict | major | closed | Not linked |
| Equipment Conflict | major | closed | Not linked |
| Equipment Conflict | major | closed | Not linked |
| Equipment Conflict | major | 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.