Batch BT-020914
Gastrivax • BSL • L015 • released
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
2025-04-03 → 2025-04-13
Actual
2024-11-09 → 2026-05-06
Exceptions
3
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010656 | Methanol HPLC Grade Variant 1 | in-process | Open workbench |
| LOT-010657 | Hydrochloric Acid 37% Variant 1 | approved | Open workbench |
| LOT-010658 | Sodium Hydroxide Variant 1 | approved | Open workbench |
| LOT-010659 | Phosphoric Acid Variant 1 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01284 Blender #285 | in-maintenance | 2026-12-02 | not-qualified |
| AST-01285 Autoclave #286 | out-of-service | 2026-03-02 | qualified |
| AST-01286 Bioreactor #287 | cleaning-required | 2025-09-30 | qualified |
| AST-01287 Centrifuge #288 | operational | 2025-05-15 | qualified |
| AST-01288 Lyophilizer #289 | operational | 2026-01-06 | requalification-due |
| AST-01289 Filling Machine #290 | operational | 2026-10-06 | not-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.