Batch BT-020116
Aziroline PED • DUB • L017 • released
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
2025-07-06 → 2025-07-19
Actual
2026-07-23 → 2025-04-23
Exceptions
9
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010464 | Polysorbate 80 Variant 5 | rejected | Open workbench |
| LOT-010465 | Mannitol Variant 5 | expired | Open workbench |
| LOT-010466 | Sucrose Variant 5 | consumed | Open workbench |
| LOT-010467 | Trehalose Variant 5 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01012 HPLC System #13 | out-of-service | 2025-02-09 | qualified |
| AST-01013 UV-Vis Spectrophotometer #14 | cleaning-required | 2025-08-09 | requalification-due |
| AST-01014 Karl Fischer Titrator #15 | operational | 2025-01-06 | not-qualified |
| AST-01015 Dissolution Tester #16 | operational | 2026-09-05 | qualified |
| AST-01016 Hardness Tester #17 | operational | 2024-07-12 | qualified |
| AST-01017 Friability Tester #18 | in-calibration | 2025-04-30 | qualified |
| AST-01018 Particle Size Analyzer #19 | in-maintenance | 2025-09-18 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | minor | under-review | Not linked |
| Material Discrepancy | minor | under-review | dev-01117 |
| Material Discrepancy | minor | under-review | Not linked |
| Material Discrepancy | minor | under-review | Not linked |
| Material Discrepancy | minor | under-review | Not linked |
| Material Discrepancy | minor | under-review | dev-00617 |
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-020116
Score: 91
EBR completionComplete
Exceptions closedOpen
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.