Batch BT-020808
Serathide • NWK • L009 • 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
2024-02-08 → 2024-02-18
Actual
2024-09-17 → 2025-06-14
Exceptions
24
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012656 | Sucrose Variant 8 | approved | Open workbench |
| LOT-012657 | Trehalose Variant 8 | approved | Open workbench |
| LOT-012658 | Histidine Buffer Variant 8 | quarantine | Open workbench |
| LOT-012659 | Sodium Chloride Variant 8 | hold | Open workbench |
| LOT-012660 | Water for Injection Variant 8 | rejected | Open workbench |
| LOT-012661 | Purified Water Variant 8 | expired | Open workbench |
| LOT-012662 | Ethanol 95% Variant 8 | consumed | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01064 Compressed Air System #65 | operational | 2024-12-23 | not-qualified |
| AST-01065 HVAC Unit #66 | operational | 2025-12-25 | qualified |
| AST-01066 Refrigerator #67 | in-calibration | 2026-05-13 | qualified |
| AST-01067 Freezer Ultra-Low #68 | in-maintenance | 2026-05-26 | qualified |
| AST-01068 Incubator #69 | out-of-service | 2025-08-21 | requalification-due |
| AST-01069 Autoclave Sterilizer #70 | cleaning-required | 2024-12-24 | not-qualified |
| AST-01070 Conveyor Belt #71 | operational | 2026-01-26 | qualified |
| AST-01071 Labeling Machine #72 | operational | 2025-07-27 | 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 | dev-00309 |
| 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.