Batch BT-020680
Neuraxin • NWK • 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
2024-09-09 → 2024-09-22
Actual
2025-05-13 → In progress
Exceptions
11
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010120 | Active Pharmaceutical Ingredient A Variant 4 | quarantine | Open workbench |
| LOT-010121 | Active Pharmaceutical Ingredient B Variant 4 | hold | Open workbench |
| LOT-010122 | Active Pharmaceutical Ingredient C Variant 4 | rejected | Open workbench |
| LOT-010123 | Microcrystalline Cellulose Variant 4 | expired | Open workbench |
| LOT-010124 | Lactose Monohydrate Variant 4 | consumed | Open workbench |
| LOT-010125 | Hydroxypropyl Methylcellulose Variant 4 | in-process | Open workbench |
| LOT-010126 | Magnesium Stearate Variant 4 | approved | Open workbench |
| LOT-010127 | Croscarmellose Sodium Variant 4 | approved | Open workbench |
| LOT-010128 | Povidone K30 Variant 4 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01080 Granulator #81 | in-calibration | 2025-12-31 | qualified |
| AST-01081 Tablet Press #82 | in-maintenance | 2024-12-18 | qualified |
| AST-01082 Film Coater #83 | out-of-service | 2025-07-29 | qualified |
| AST-01083 Capsule Filler #84 | cleaning-required | 2025-04-29 | requalification-due |
| AST-01084 Blender #85 | operational | 2025-11-14 | not-qualified |
| AST-01085 Autoclave #86 | operational | 2025-05-11 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Out of Specification | critical | open | dev-00681 |
| Out of Specification | critical | open | dev-00181 |
| Out of Specification | critical | open | dev-01181 |
| Out of Specification | critical | open | Not linked |
| Out of Specification | critical | open | Not linked |
| Out of Specification | 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.