Batch BT-020182
Celdurin • CMO1 • L033 • 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
2024-12-16 → 2024-12-25
Actual
2025-05-01 → 2025-06-18
Exceptions
6
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011456 | Sucrose Variant 8 | consumed | Open workbench |
| LOT-011457 | Trehalose Variant 8 | in-process | Open workbench |
| LOT-011458 | Histidine Buffer Variant 8 | approved | Open workbench |
| LOT-011459 | Sodium Chloride Variant 8 | approved | Open workbench |
| LOT-011460 | Water for Injection Variant 8 | approved | Open workbench |
| LOT-011461 | Purified Water Variant 8 | quarantine | Open workbench |
| LOT-011462 | Ethanol 95% Variant 8 | hold | Open workbench |
| LOT-011463 | Isopropyl Alcohol Variant 8 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01328 Lyophilizer #329 | cleaning-required | 2025-07-09 | requalification-due |
| AST-01329 Filling Machine #330 | operational | 2026-03-08 | not-qualified |
| AST-01330 Visual Inspection System #331 | operational | 2025-10-19 | qualified |
| AST-01331 Weighing Balance #332 | operational | 2026-05-18 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | dev-00683 |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | dev-01183 |
| Procedure Deviation | major | under-review | 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-020182
Score: 98
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedOpen
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.