Batch BT-020333
Celdurin IV • PPL • L034 • 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
2026-07-19 → 2026-07-23
Actual
2024-07-06 → 2025-01-02
Exceptions
16
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010999 | Talc Variant 3 | approved | Open workbench |
| LOT-011000 | Colloidal Silicon Dioxide Variant 3 | approved | Open workbench |
| LOT-011001 | Stearic Acid Variant 3 | 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 | Not linked |
| Environmental Excursion | major | closed | Not linked |
| Environmental Excursion | major | closed | dev-00834 |
| Environmental Excursion | major | closed | dev-00334 |
| Environmental Excursion | major | closed | Not linked |
| Environmental Excursion | 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.
Release Readiness: BT-020333
Score: 88
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantOpen
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.