Batch BT-020860
Neuraxin • DUB • L011 • 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
2025-04-07 → 2025-04-18
Actual
2024-05-18 → In progress
Exceptions
4
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010020 | Water for Injection | approved | Open workbench |
| LOT-010021 | Purified Water | quarantine | Open workbench |
| LOT-010022 | Ethanol 95% | hold | Open workbench |
| LOT-010023 | Isopropyl Alcohol | rejected | Open workbench |
| LOT-010024 | Methylene Chloride | expired | Open workbench |
| LOT-010025 | Acetonitrile HPLC Grade | consumed | Open workbench |
| LOT-010026 | Methanol HPLC Grade | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01360 Granulator #361 | in-calibration | 2025-10-29 | qualified |
| AST-01361 Tablet Press #362 | in-maintenance | 2025-09-28 | qualified |
| AST-01362 Film Coater #363 | out-of-service | 2025-09-22 | qualified |
| AST-01363 Capsule Filler #364 | cleaning-required | 2024-11-11 | requalification-due |
| AST-01364 Blender #365 | operational | 2025-04-05 | not-qualified |
| AST-01365 Autoclave #366 | operational | 2025-03-29 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | critical | open | dev-00861 |
| Material Discrepancy | critical | open | dev-00361 |
| Material Discrepancy | critical | open | Not linked |
| Material Discrepancy | critical | open | Not linked |
| Material Discrepancy | critical | open | Not linked |
| Material Discrepancy | critical | open | 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.