Batch BT-020350
Neuraxin • CMO1 • L001 • 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
2024-12-19 → 2024-12-26
Actual
2024-04-23 → In progress
Exceptions
7
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011050 | Active Pharmaceutical Ingredient A Variant 5 | expired | Open workbench |
| LOT-011051 | Active Pharmaceutical Ingredient B Variant 5 | consumed | Open workbench |
| LOT-011052 | Active Pharmaceutical Ingredient C Variant 5 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01100 Laminar Flow Cabinet #101 | operational | 2025-11-13 | qualified |
| AST-01101 Isolator #102 | in-calibration | 2024-07-18 | qualified |
| AST-01102 WFI Still #103 | in-maintenance | 2025-12-13 | qualified |
| AST-01103 RO System #104 | out-of-service | 2025-09-05 | requalification-due |
| AST-01104 Compressed Air System #105 | cleaning-required | 2025-03-16 | not-qualified |
| AST-01105 HVAC Unit #106 | operational | 2025-02-26 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | 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.
Release Readiness: BT-020350
Score: 95
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.