Batch BT-020107
Eptiveron • SGP • L008 • 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
2025-05-06 → 2025-05-19
Actual
2026-03-31 → In progress
Exceptions
11
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010321 | Purified Water | expired | Open workbench |
| LOT-010322 | Ethanol 95% | consumed | Open workbench |
| LOT-010323 | Isopropyl Alcohol | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01214 Karl Fischer Titrator #215 | in-maintenance | 2026-05-26 | not-qualified |
| AST-01215 Dissolution Tester #216 | out-of-service | 2026-07-27 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Equipment Conflict | minor | under-review | dev-00108 |
| 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 | Not linked |
| Equipment Conflict | minor | under-review | dev-00608 |
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-020107
Score: 60
EBR completionComplete
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.