Batch BT-020648
Eptiveron HD • NWK • L049 • 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
2024-05-25 → 2024-06-08
Actual
2025-11-02 → 2026-08-14
Exceptions
10
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010240 | Active Pharmaceutical Ingredient A Variant 8 | expired | Open workbench |
| LOT-010241 | Active Pharmaceutical Ingredient B Variant 8 | consumed | Open workbench |
| LOT-010242 | Active Pharmaceutical Ingredient C Variant 8 | in-process | Open workbench |
| LOT-010243 | Microcrystalline Cellulose Variant 8 | approved | Open workbench |
| LOT-010244 | Lactose Monohydrate Variant 8 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01344 Compressed Air System #345 | operational | 2025-05-15 | not-qualified |
| AST-01345 HVAC Unit #346 | operational | 2026-03-28 | qualified |
| AST-01346 Refrigerator #347 | in-calibration | 2025-11-24 | 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 | Not linked |
| 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.