Batch BT-020573
Celdurin IV • PPL • L024 • 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
2025-09-07 → 2025-09-18
Actual
2025-10-22 → 2026-01-08
Exceptions
24
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012292 | Titanium Dioxide Variant 6 | expired | Open workbench |
| LOT-012293 | Polyethylene Glycol 400 Variant 6 | consumed | Open workbench |
| LOT-012294 | Polysorbate 80 Variant 6 | in-process | Open workbench |
| LOT-012295 | Mannitol Variant 6 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01065 HVAC Unit #66 | operational | 2025-12-25 | qualified |
| AST-01066 Refrigerator #67 | in-calibration | 2026-05-13 | qualified |
| AST-01067 Freezer Ultra-Low #68 | in-maintenance | 2026-05-26 | qualified |
| AST-01068 Incubator #69 | out-of-service | 2025-08-21 | requalification-due |
| AST-01069 Autoclave Sterilizer #70 | cleaning-required | 2024-12-24 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | major | closed | dev-00574 |
| Environmental Excursion | major | closed | Not linked |
| Environmental Excursion | major | closed | Not linked |
| Environmental Excursion | major | closed | Not linked |
| Environmental Excursion | major | closed | Not linked |
| Environmental Excursion | major | closed | dev-01074 |
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.