Batch BT-020836
Aziroline PED • DUB • L037 • 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
2024-06-07 → 2024-06-14
Actual
2024-09-24 → 2025-02-07
Exceptions
19
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012016 | Magnesium Stearate Variant 7 | approved | Open workbench |
| LOT-012017 | Croscarmellose Sodium Variant 7 | approved | Open workbench |
| LOT-012018 | Povidone K30 Variant 7 | approved | Open workbench |
| LOT-012019 | Talc Variant 7 | quarantine | Open workbench |
| LOT-012020 | Colloidal Silicon Dioxide Variant 7 | hold | Open workbench |
| LOT-012021 | Stearic Acid Variant 7 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01288 Lyophilizer #289 | operational | 2026-01-06 | requalification-due |
| AST-01289 Filling Machine #290 | operational | 2026-10-06 | not-qualified |
| AST-01290 Visual Inspection System #291 | in-calibration | 2025-07-30 | qualified |
| AST-01291 Weighing Balance #292 | in-maintenance | 2026-05-11 | qualified |
| AST-01292 HPLC System #293 | out-of-service | 2024-08-18 | qualified |
| AST-01293 UV-Vis Spectrophotometer #294 | cleaning-required | 2025-09-10 | requalification-due |
| AST-01294 Karl Fischer Titrator #295 | operational | 2024-11-01 | not-qualified |
| AST-01295 Dissolution Tester #296 | operational | 2025-04-03 | qualified |
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 | Not linked |
| 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 | 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.
No release readiness record found.