Batch BT-020332
Celdurin • DUB • 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
2025-10-19 → 2025-10-25
Actual
2024-12-21 → 2025-05-06
Exceptions
10
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012988 | Histidine Buffer Variant 9 | approved | Open workbench |
| LOT-012989 | Sodium Chloride Variant 9 | approved | Open workbench |
| LOT-012990 | Water for Injection Variant 9 | approved | Open workbench |
| LOT-012991 | Purified Water Variant 9 | quarantine | Open workbench |
| LOT-012992 | Ethanol 95% Variant 9 | hold | Open workbench |
| LOT-012993 | Isopropyl Alcohol Variant 9 | rejected | Open workbench |
| LOT-012994 | Methylene Chloride Variant 9 | expired | Open workbench |
| LOT-012995 | Acetonitrile HPLC Grade Variant 9 | consumed | Open workbench |
| LOT-012996 | Methanol HPLC Grade Variant 9 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01256 Hardness Tester #257 | in-maintenance | 2025-07-11 | qualified |
| AST-01257 Friability Tester #258 | out-of-service | 2026-10-02 | qualified |
| AST-01258 Particle Size Analyzer #259 | cleaning-required | 2026-10-10 | requalification-due |
| AST-01259 Microscope #260 | operational | 2026-08-31 | not-qualified |
| AST-01260 Laminar Flow Cabinet #261 | operational | 2025-05-26 | qualified |
| AST-01261 Isolator #262 | operational | 2025-04-05 | qualified |
| AST-01262 WFI Still #263 | in-calibration | 2025-12-30 | qualified |
| AST-01263 RO System #264 | in-maintenance | 2025-10-05 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | major | under-review | dev-00333 |
| Material Discrepancy | major | under-review | Not linked |
| Material Discrepancy | major | under-review | Not linked |
| Material Discrepancy | major | under-review | Not linked |
| Material Discrepancy | major | under-review | Not linked |
| Material Discrepancy | 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-020332
Score: 80
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.