Batch BT-020562
Hemovance • BSL • L013 • 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
2025-10-15 → 2025-10-19
Actual
2025-02-14 → 2025-08-26
Exceptions
24
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012248 | Sodium Hydroxide Variant 4 | consumed | Open workbench |
| LOT-012249 | Phosphoric Acid Variant 4 | in-process | Open workbench |
| LOT-012250 | Active Pharmaceutical Ingredient A Variant 5 | approved | Open workbench |
| LOT-012251 | Active Pharmaceutical Ingredient B Variant 5 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01334 Karl Fischer Titrator #335 | out-of-service | 2024-11-14 | not-qualified |
| AST-01335 Dissolution Tester #336 | cleaning-required | 2024-12-18 | qualified |
| AST-01336 Hardness Tester #337 | operational | 2026-03-12 | qualified |
| AST-01337 Friability Tester #338 | operational | 2025-07-15 | qualified |
| AST-01338 Particle Size Analyzer #339 | operational | 2025-08-08 | requalification-due |
| AST-01339 Microscope #340 | in-calibration | 2026-06-15 | not-qualified |
| AST-01340 Laminar Flow Cabinet #341 | in-maintenance | 2026-06-10 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
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.