Batch BT-020243
Celdurin IV • SGP • L044 • 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
2024-04-13 → 2024-04-18
Actual
2026-10-31 → 2024-01-01
Exceptions
21
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011215 | Mannitol | approved | Open workbench |
| LOT-011216 | Sucrose | approved | Open workbench |
| LOT-011217 | Trehalose | approved | Open workbench |
| LOT-011218 | Histidine Buffer | quarantine | Open workbench |
| LOT-011219 | Sodium Chloride | hold | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01101 Isolator #102 | in-calibration | 2024-07-18 | qualified |
| AST-01102 WFI Still #103 | in-maintenance | 2025-12-13 | qualified |
| AST-01103 RO System #104 | out-of-service | 2025-09-05 | requalification-due |
| AST-01104 Compressed Air System #105 | cleaning-required | 2025-03-16 | not-qualified |
| AST-01105 HVAC Unit #106 | operational | 2025-02-26 | qualified |
| AST-01106 Refrigerator #107 | operational | 2025-06-01 | qualified |
| AST-01107 Freezer Ultra-Low #108 | operational | 2026-02-09 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Equipment Conflict | major | closed | dev-00244 |
| 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.
Release Readiness: BT-020243
Score: 67
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantOpen
Training confirmedOpen
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.