Batch BT-020330
Veranide • BSL • 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
2024-09-06 → 2024-09-17
Actual
2024-11-23 → In progress
Exceptions
14
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011980 | Active Pharmaceutical Ingredient A Variant 6 | approved | Open workbench |
| LOT-011981 | Active Pharmaceutical Ingredient B Variant 6 | approved | Open workbench |
| LOT-011982 | Active Pharmaceutical Ingredient C Variant 6 | approved | Open workbench |
| LOT-011983 | Microcrystalline Cellulose Variant 6 | quarantine | Open workbench |
| LOT-011984 | Lactose Monohydrate Variant 6 | hold | Open workbench |
| LOT-011985 | Hydroxypropyl Methylcellulose Variant 6 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01310 Conveyor Belt #311 | operational | 2026-02-22 | qualified |
| AST-01311 Labeling Machine #312 | in-calibration | 2025-01-14 | qualified |
| AST-01312 Cartoning Machine #313 | in-maintenance | 2025-05-11 | qualified |
| AST-01313 Blister Packer #314 | out-of-service | 2026-05-26 | requalification-due |
| AST-01314 Shrink Wrapper #315 | cleaning-required | 2024-10-05 | not-qualified |
| AST-01315 Checkweigher #316 | operational | 2024-12-28 | qualified |
| AST-01316 Metal Detector #317 | operational | 2026-01-11 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
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-020330
Score: 90
EBR completionOpen
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.