Batch BT-020534
Vakrofen ER • CMO1 • L035 • 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
2026-12-05 → 2026-12-18
Actual
2026-01-23 → 2025-07-16
Exceptions
5
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010204 | Methylene Chloride Variant 6 | expired | Open workbench |
| LOT-010205 | Acetonitrile HPLC Grade Variant 6 | consumed | Open workbench |
| LOT-010206 | Methanol HPLC Grade Variant 6 | in-process | Open workbench |
| LOT-010207 | Hydrochloric Acid 37% Variant 6 | approved | Open workbench |
| LOT-010208 | Sodium Hydroxide Variant 6 | approved | Open workbench |
| LOT-010209 | Phosphoric Acid Variant 6 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01004 Blender #5 | in-maintenance | 2024-05-29 | not-qualified |
| AST-01005 Autoclave #6 | out-of-service | 2025-07-22 | qualified |
| AST-01006 Bioreactor #7 | cleaning-required | 2024-12-27 | qualified |
| AST-01007 Centrifuge #8 | operational | 2025-09-28 | qualified |
| AST-01008 Lyophilizer #9 | operational | 2026-08-12 | requalification-due |
| AST-01009 Filling Machine #10 | operational | 2026-08-10 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | 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.