Batch BT-020263
Vakrofen • CMO2 • L014 • completed
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
2024-10-26 → 2024-11-08
Actual
2025-07-27 → 2026-10-09
Exceptions
24
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012104 | Lactose Monohydrate | consumed | Open workbench |
| LOT-012105 | Hydroxypropyl Methylcellulose | in-process | Open workbench |
| LOT-012106 | Magnesium Stearate | approved | Open workbench |
| LOT-012107 | Croscarmellose Sodium | approved | Open workbench |
| LOT-012108 | Povidone K30 | approved | Open workbench |
| LOT-012109 | Talc | quarantine | Open workbench |
| LOT-012110 | Colloidal Silicon Dioxide | hold | Open workbench |
| LOT-012111 | Stearic Acid | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01126 Bioreactor #127 | operational | 2026-01-30 | qualified |
| AST-01127 Centrifuge #128 | operational | 2026-02-27 | 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-020263
Score: 72
EBR completionOpen
Exceptions closedComplete
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.