Batch BT-020528
Eptiveron HD • NWK • L029 • 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
2025-12-29 → 2026-01-03
Actual
2024-08-23 → 2025-12-01
Exceptions
0
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012112 | Titanium Dioxide | expired | Open workbench |
| LOT-012113 | Polyethylene Glycol 400 | consumed | Open workbench |
| LOT-012114 | Polysorbate 80 | in-process | Open workbench |
| LOT-012115 | Mannitol | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01368 Lyophilizer #369 | in-maintenance | 2026-10-03 | requalification-due |
| AST-01369 Filling Machine #370 | out-of-service | 2025-09-02 | not-qualified |
| AST-01370 Visual Inspection System #371 | cleaning-required | 2025-04-13 | qualified |
| AST-01371 Weighing Balance #372 | operational | 2025-10-07 | qualified |
| AST-01372 HPLC System #373 | operational | 2026-10-31 | qualified |
| AST-01373 UV-Vis Spectrophotometer #374 | operational | 2025-01-15 | requalification-due |
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-01029 |
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | Not linked |
| Out of Specification | 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.
No release readiness record found.