Batch BT-020460
Nexipar • 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
2026-07-29 → 2026-08-07
Actual
2026-09-23 → In progress
Exceptions
14
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011840 | Colloidal Silicon Dioxide Variant 1 | hold | Open workbench |
| LOT-011841 | Stearic Acid Variant 1 | rejected | Open workbench |
| LOT-011842 | Titanium Dioxide Variant 1 | expired | Open workbench |
| LOT-011843 | Polyethylene Glycol 400 Variant 1 | consumed | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01300 Laminar Flow Cabinet #301 | cleaning-required | 2026-07-05 | qualified |
| AST-01301 Isolator #302 | operational | 2026-03-10 | qualified |
| AST-01302 WFI Still #303 | operational | 2025-11-25 | qualified |
| AST-01303 RO System #304 | operational | 2026-05-07 | requalification-due |
| AST-01304 Compressed Air System #305 | in-calibration | 2026-05-29 | not-qualified |
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 | 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-020460
Score: 100
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.