Batch BT-020199
Corazyme • CMO2 • L050 • planned
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
2025-06-18 → 2025-06-23
Actual
Pending → In progress
Exceptions
20
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011990 | Colloidal Silicon Dioxide Variant 6 | approved | Open workbench |
| LOT-011991 | Stearic Acid Variant 6 | approved | Open workbench |
| LOT-011992 | Titanium Dioxide Variant 6 | quarantine | Open workbench |
| LOT-011993 | Polyethylene Glycol 400 Variant 6 | hold | Open workbench |
| LOT-011994 | Polysorbate 80 Variant 6 | rejected | Open workbench |
| LOT-011995 | Mannitol Variant 6 | expired | Open workbench |
| LOT-011996 | Sucrose Variant 6 | consumed | Open workbench |
| LOT-011997 | Trehalose Variant 6 | in-process | Open workbench |
| LOT-011998 | Histidine Buffer Variant 6 | approved | Open workbench |
| LOT-011999 | Sodium Chloride Variant 6 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01394 Shrink Wrapper #395 | operational | 2026-03-22 | not-qualified |
| AST-01395 Checkweigher #396 | in-calibration | 2025-10-15 | qualified |
| AST-01396 Metal Detector #397 | in-maintenance | 2024-07-09 | qualified |
| AST-01397 X-Ray Inspection #398 | out-of-service | 2024-12-22 | qualified |
| AST-01398 Leak Tester #399 | cleaning-required | 2025-03-11 | requalification-due |
| AST-01399 Torque Tester #400 | operational | 2024-12-04 | not-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-020199
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.