Batch BT-020798
Eptiveron HD • CMO1 • 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
2025-08-26 → 2025-08-29
Actual
2026-07-25 → 2025-12-12
Exceptions
20
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011788 | Histidine Buffer Variant 9 | expired | Open workbench |
| LOT-011789 | Sodium Chloride Variant 9 | consumed | Open workbench |
| LOT-011790 | Water for Injection Variant 9 | in-process | Open workbench |
| LOT-011791 | Purified Water Variant 9 | approved | Open workbench |
| LOT-011792 | Ethanol 95% Variant 9 | approved | Open workbench |
| LOT-011793 | Isopropyl Alcohol Variant 9 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01392 Cartoning Machine #393 | operational | 2026-04-18 | qualified |
| AST-01393 Blister Packer #394 | operational | 2026-02-20 | requalification-due |
| AST-01394 Shrink Wrapper #395 | operational | 2026-03-22 | not-qualified |
| AST-01395 Checkweigher #396 | in-calibration | 2025-10-15 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | 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.