Batch BT-020652
Hemovance • DUB • L003 • completed
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
2026-07-11 → 2026-07-15
Actual
2026-09-30 → 2025-12-28
Exceptions
21
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010260 | Water for Injection Variant 8 | in-process | Open workbench |
| LOT-010261 | Purified Water Variant 8 | approved | Open workbench |
| LOT-010262 | Ethanol 95% Variant 8 | approved | Open workbench |
| LOT-010263 | Isopropyl Alcohol Variant 8 | approved | Open workbench |
| LOT-010264 | Methylene Chloride Variant 8 | quarantine | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01208 Lyophilizer #209 | out-of-service | 2025-11-29 | requalification-due |
| AST-01209 Filling Machine #210 | cleaning-required | 2025-06-11 | not-qualified |
| AST-01210 Visual Inspection System #211 | operational | 2025-07-06 | qualified |
| AST-01211 Weighing Balance #212 | operational | 2025-04-26 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | major | under-review | Not linked |
| Material Discrepancy | major | under-review | Not linked |
| Material Discrepancy | major | under-review | dev-01153 |
| Material Discrepancy | major | under-review | Not linked |
| Material Discrepancy | major | under-review | dev-00153 |
| Material Discrepancy | major | under-review | 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.