Batch BT-020414
Vakrofen ER • CMO1 • L015 • released
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
2024-04-17 → 2024-04-21
Actual
2025-04-04 → 2026-06-04
Exceptions
2
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010726 | Magnesium Stearate Variant 4 | expired | Open workbench |
| LOT-010727 | Croscarmellose Sodium Variant 4 | consumed | Open workbench |
| LOT-010728 | Povidone K30 Variant 4 | in-process | Open workbench |
| LOT-010729 | Talc Variant 4 | approved | Open workbench |
| LOT-010730 | Colloidal Silicon Dioxide Variant 4 | approved | Open workbench |
| LOT-010731 | Stearic Acid Variant 4 | approved | Open workbench |
| LOT-010732 | Titanium Dioxide Variant 4 | quarantine | Open workbench |
| LOT-010733 | Polyethylene Glycol 400 Variant 4 | hold | Open workbench |
| LOT-010734 | Polysorbate 80 Variant 4 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01098 Particle Size Analyzer #99 | operational | 2025-09-27 | requalification-due |
| AST-01099 Microscope #100 | operational | 2026-03-30 | not-qualified |
| 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 |
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-020414
Score: 74
EBR completionComplete
Exceptions closedOpen
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedOpen
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.