Batch BT-020502
Hemovance • CMO1 • 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
2026-04-13 → 2026-04-24
Actual
2025-09-30 → 2024-12-07
Exceptions
23
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012510 | Water for Injection Variant 3 | in-process | Open workbench |
| LOT-012511 | Purified Water Variant 3 | approved | Open workbench |
| LOT-012512 | Ethanol 95% Variant 3 | approved | Open workbench |
| LOT-012513 | Isopropyl Alcohol Variant 3 | approved | Open workbench |
| LOT-012514 | Methylene Chloride Variant 3 | quarantine | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01016 Hardness Tester #17 | operational | 2024-07-12 | qualified |
| AST-01017 Friability Tester #18 | in-calibration | 2025-04-30 | qualified |
| AST-01018 Particle Size Analyzer #19 | in-maintenance | 2025-09-18 | requalification-due |
| AST-01019 Microscope #20 | out-of-service | 2026-03-22 | not-qualified |
| AST-01020 Laminar Flow Cabinet #21 | cleaning-required | 2025-06-20 | qualified |
| AST-01021 Isolator #22 | operational | 2025-12-23 | qualified |
| AST-01022 WFI Still #23 | operational | 2025-10-20 | qualified |
| AST-01023 RO System #24 | operational | 2024-12-20 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | dev-00003 |
| Procedure Deviation | major | under-review | dev-01003 |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | 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.