Batch BT-020372
Dermazol • DUB • L023 • 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
2026-11-02 → 2026-11-14
Actual
2024-05-31 → 2026-01-20
Exceptions
22
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011860 | Active Pharmaceutical Ingredient A Variant 2 | expired | Open workbench |
| LOT-011861 | Active Pharmaceutical Ingredient B Variant 2 | consumed | Open workbench |
| LOT-011862 | Active Pharmaceutical Ingredient C Variant 2 | in-process | Open workbench |
| LOT-011863 | Microcrystalline Cellulose Variant 2 | approved | Open workbench |
| LOT-011864 | Lactose Monohydrate Variant 2 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01204 Blender #205 | operational | 2026-06-23 | not-qualified |
| AST-01205 Autoclave #206 | operational | 2026-01-12 | qualified |
| AST-01206 Bioreactor #207 | in-calibration | 2026-08-01 | qualified |
| AST-01207 Centrifuge #208 | in-maintenance | 2025-10-24 | qualified |
| AST-01208 Lyophilizer #209 | out-of-service | 2025-11-29 | requalification-due |
| AST-01209 Filling Machine #210 | cleaning-required | 2025-06-11 | not-qualified |
| AST-01210 Visual Inspection System #211 | operational | 2025-07-06 | qualified |
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 | dev-01373 |
| Material Discrepancy | major | under-review | dev-00873 |
| 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-020372
Score: 94
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.