Batch BT-020947
Eptiveron • SGP • L048 • on-hold
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
2025-05-23 → 2025-05-29
Actual
2026-10-09 → In progress
Exceptions
11
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012841 | Purified Water Variant 4 | expired | Open workbench |
| LOT-012842 | Ethanol 95% Variant 4 | consumed | Open workbench |
| LOT-012843 | Isopropyl Alcohol Variant 4 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01188 Incubator #189 | cleaning-required | 2025-04-29 | requalification-due |
| AST-01189 Autoclave Sterilizer #190 | operational | 2025-04-13 | not-qualified |
| AST-01190 Conveyor Belt #191 | operational | 2024-05-15 | qualified |
| AST-01191 Labeling Machine #192 | operational | 2025-08-01 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Equipment Conflict | minor | under-review | Not linked |
| Equipment Conflict | minor | under-review | dev-00448 |
| Equipment Conflict | minor | under-review | Not linked |
| Equipment Conflict | minor | under-review | Not linked |
| Equipment Conflict | minor | under-review | Not linked |
| Equipment Conflict | minor | under-review | dev-01448 |
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.
No release readiness record found.