Batch BT-020980
Neuraxin • DUB • L031 • in-process
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
2024-05-24 → 2024-05-28
Actual
2024-01-25 → In progress
Exceptions
5
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010860 | Water for Injection Variant 8 | rejected | Open workbench |
| LOT-010861 | Purified Water Variant 8 | expired | Open workbench |
| LOT-010862 | Ethanol 95% Variant 8 | consumed | Open workbench |
| LOT-010863 | Isopropyl Alcohol Variant 8 | in-process | Open workbench |
| LOT-010864 | Methylene Chloride Variant 8 | approved | Open workbench |
| LOT-010865 | Acetonitrile HPLC Grade Variant 8 | approved | Open workbench |
| LOT-010866 | Methanol HPLC Grade Variant 8 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01240 Granulator #241 | operational | 2024-11-17 | qualified |
| AST-01241 Tablet Press #242 | in-calibration | 2025-12-06 | qualified |
| AST-01242 Film Coater #243 | in-maintenance | 2026-03-03 | qualified |
| AST-01243 Capsule Filler #244 | out-of-service | 2026-02-09 | requalification-due |
| AST-01244 Blender #245 | cleaning-required | 2026-04-06 | not-qualified |
| AST-01245 Autoclave #246 | operational | 2026-09-16 | qualified |
| AST-01246 Bioreactor #247 | operational | 2025-09-11 | qualified |
| AST-01247 Centrifuge #248 | operational | 2026-02-10 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | critical | open | dev-00981 |
| Material Discrepancy | critical | open | Not linked |
| Material Discrepancy | critical | open | Not linked |
| Material Discrepancy | critical | open | Not linked |
| Material Discrepancy | critical | open | dev-00481 |
| Material Discrepancy | critical | open | dev-01481 |
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.