Batch BT-020212
Celdurin • DUB • L013 • 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
2025-01-14 → 2025-01-18
Actual
2025-08-23 → 2024-09-26
Exceptions
17
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011484 | Polysorbate 80 Variant 9 | in-process | Open workbench |
| LOT-011485 | Mannitol Variant 9 | approved | Open workbench |
| LOT-011486 | Sucrose Variant 9 | approved | Open workbench |
| LOT-011487 | Trehalose Variant 9 | approved | Open workbench |
| LOT-011488 | Histidine Buffer Variant 9 | quarantine | Open workbench |
| LOT-011489 | Sodium Chloride Variant 9 | hold | Open workbench |
| LOT-011490 | Water for Injection Variant 9 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01096 Hardness Tester #97 | out-of-service | 2025-05-03 | qualified |
| AST-01097 Friability Tester #98 | cleaning-required | 2024-12-15 | qualified |
| AST-01098 Particle Size Analyzer #99 | operational | 2025-09-27 | requalification-due |
| AST-01099 Microscope #100 | operational | 2026-03-30 | not-qualified |
| AST-01100 Laminar Flow Cabinet #101 | operational | 2025-11-13 | qualified |
| 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 |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| 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 | dev-01213 |
| 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-020212
Score: 100
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.