Batch BT-020194
Gastrivax • BSL • L045 • 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
2025-11-29 → 2025-12-02
Actual
2025-10-21 → 2026-08-22
Exceptions
1
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010582 | Titanium Dioxide Variant 9 | expired | Open workbench |
| LOT-010583 | Polyethylene Glycol 400 Variant 9 | consumed | Open workbench |
| LOT-010584 | Polysorbate 80 Variant 9 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01170 Visual Inspection System #171 | operational | 2025-02-18 | qualified |
| AST-01171 Weighing Balance #172 | in-calibration | 2025-05-11 | qualified |
| AST-01172 HPLC System #173 | in-maintenance | 2026-03-24 | qualified |
| AST-01173 UV-Vis Spectrophotometer #174 | out-of-service | 2024-07-28 | requalification-due |
| AST-01174 Karl Fischer Titrator #175 | cleaning-required | 2025-12-31 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Late Step | minor | closed | Not linked |
| Late Step | minor | closed | Not linked |
| Late Step | minor | closed | Not linked |
| Late Step | minor | closed | Not linked |
| Late Step | minor | closed | Not linked |
| Late Step | minor | closed | Not linked |
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-020194
Score: 69
EBR completionComplete
Exceptions closedComplete
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.