Batch BT-020138
Eptiveron HD • BSL • L039 • rejected
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
2024-06-15 → 2024-06-28
Actual
2024-07-17 → 2025-09-27
Exceptions
19
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010690 | Active Pharmaceutical Ingredient A Variant 3 | expired | Open workbench |
| LOT-010691 | Active Pharmaceutical Ingredient B Variant 3 | consumed | Open workbench |
| LOT-010692 | Active Pharmaceutical Ingredient C Variant 3 | in-process | Open workbench |
| LOT-010693 | Microcrystalline Cellulose Variant 3 | approved | Open workbench |
| LOT-010694 | Lactose Monohydrate Variant 3 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01028 Incubator #29 | operational | 2024-08-03 | requalification-due |
| AST-01029 Autoclave Sterilizer #30 | operational | 2024-11-19 | not-qualified |
| AST-01030 Conveyor Belt #31 | operational | 2026-04-11 | qualified |
| AST-01031 Labeling Machine #32 | in-calibration | 2025-12-17 | qualified |
| AST-01032 Cartoning Machine #33 | in-maintenance | 2026-03-01 | qualified |
| AST-01033 Blister Packer #34 | out-of-service | 2025-04-21 | requalification-due |
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-020138
Score: 72
EBR completionOpen
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedComplete
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.