Batch BT-020380
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
2026-10-05 → 2026-10-10
Actual
2025-06-14 → In progress
Exceptions
19
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010800 | Water for Injection Variant 6 | in-process | Open workbench |
| LOT-010801 | Purified Water Variant 6 | approved | Open workbench |
| LOT-010802 | Ethanol 95% Variant 6 | approved | Open workbench |
| LOT-010803 | Isopropyl Alcohol Variant 6 | approved | Open workbench |
| LOT-010804 | Methylene Chloride Variant 6 | quarantine | Open workbench |
| LOT-010805 | Acetonitrile HPLC Grade Variant 6 | hold | Open workbench |
| LOT-010806 | Methanol HPLC Grade Variant 6 | rejected | Open workbench |
| LOT-010807 | Hydrochloric Acid 37% Variant 6 | expired | Open workbench |
| LOT-010808 | Sodium Hydroxide Variant 6 | consumed | Open workbench |
| LOT-010809 | Phosphoric Acid Variant 6 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01320 Granulator #321 | out-of-service | 2026-03-30 | qualified |
| AST-01321 Tablet Press #322 | cleaning-required | 2025-04-30 | qualified |
| AST-01322 Film Coater #323 | operational | 2025-04-11 | qualified |
| AST-01323 Capsule Filler #324 | operational | 2025-10-01 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | critical | open | Not linked |
| Material Discrepancy | critical | open | Not linked |
| Material Discrepancy | critical | open | Not linked |
| Material Discrepancy | critical | open | Not linked |
| Material Discrepancy | critical | open | Not linked |
| Material Discrepancy | critical | open | dev-00881 |
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-020380
Score: 73
EBR completionComplete
Exceptions closedOpen
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.