Batch BT-020294
Vakrofen ER • CMO1 • L045 • 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
2026-11-24 → 2026-11-30
Actual
2025-06-26 → 2026-03-09
Exceptions
14
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011470 | Active Pharmaceutical Ingredient A Variant 9 | quarantine | Open workbench |
| LOT-011471 | Active Pharmaceutical Ingredient B Variant 9 | hold | Open workbench |
| LOT-011472 | Active Pharmaceutical Ingredient C Variant 9 | rejected | Open workbench |
| LOT-011473 | Microcrystalline Cellulose Variant 9 | expired | Open workbench |
| LOT-011474 | Lactose Monohydrate Variant 9 | consumed | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01164 Blender #165 | in-calibration | 2025-09-18 | not-qualified |
| AST-01165 Autoclave #166 | in-maintenance | 2025-08-05 | qualified |
| AST-01166 Bioreactor #167 | out-of-service | 2025-07-30 | qualified |
| AST-01167 Centrifuge #168 | cleaning-required | 2024-12-24 | qualified |
| AST-01168 Lyophilizer #169 | operational | 2024-06-02 | requalification-due |
| AST-01169 Filling Machine #170 | operational | 2026-04-30 | 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 | dev-01295 |
| 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.
Release Readiness: BT-020294
Score: 79
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.