Batch BT-020682
Hemovance • BSL • L033 • 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
2025-07-04 → 2025-07-09
Actual
2026-09-23 → 2026-12-13
Exceptions
3
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012728 | Sodium Hydroxide | approved | Open workbench |
| LOT-012729 | Phosphoric Acid | approved | Open workbench |
| LOT-012730 | Active Pharmaceutical Ingredient A Variant 1 | quarantine | Open workbench |
| LOT-012731 | Active Pharmaceutical Ingredient B Variant 1 | hold | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01374 Karl Fischer Titrator #375 | in-calibration | 2026-05-11 | not-qualified |
| AST-01375 Dissolution Tester #376 | in-maintenance | 2024-08-23 | qualified |
| AST-01376 Hardness Tester #377 | out-of-service | 2026-09-13 | qualified |
| AST-01377 Friability Tester #378 | cleaning-required | 2025-09-10 | qualified |
| AST-01378 Particle Size Analyzer #379 | operational | 2024-07-06 | requalification-due |
| AST-01379 Microscope #380 | operational | 2025-05-06 | not-qualified |
| AST-01380 Laminar Flow Cabinet #381 | operational | 2024-09-07 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Late Step | major | under-review | Not linked |
| Late Step | major | under-review | Not linked |
| Late Step | major | under-review | Not linked |
| Late Step | major | under-review | Not linked |
| Late Step | major | under-review | Not linked |
| Late Step | 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.