Batch BT-020384
Vakrofen ER • NWK • L035 • 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
2024-11-21 → 2024-11-24
Actual
2024-01-08 → 2025-09-05
Exceptions
22
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011152 | Titanium Dioxide Variant 8 | approved | Open workbench |
| LOT-011153 | Polyethylene Glycol 400 Variant 8 | approved | Open workbench |
| LOT-011154 | Polysorbate 80 Variant 8 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01336 Hardness Tester #337 | operational | 2026-03-12 | qualified |
| AST-01337 Friability Tester #338 | operational | 2025-07-15 | qualified |
| AST-01338 Particle Size Analyzer #339 | operational | 2025-08-08 | requalification-due |
| AST-01339 Microscope #340 | in-calibration | 2026-06-15 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | dev-00885 |
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | dev-01385 |
| Out of Specification | minor | closed | dev-00885 |
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-020384
Score: 91
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedOpen
Calibration compliantOpen
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.