Batch BT-020444
Vakrofen ER • DUB • 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
2025-10-27 → 2025-11-05
Actual
2025-02-05 → 2024-01-26
Exceptions
1
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010108 | Histidine Buffer Variant 3 | approved | Open workbench |
| LOT-010109 | Sodium Chloride Variant 3 | approved | Open workbench |
| LOT-010110 | Water for Injection Variant 3 | approved | Open workbench |
| LOT-010111 | Purified Water Variant 3 | quarantine | Open workbench |
| LOT-010112 | Ethanol 95% Variant 3 | hold | Open workbench |
| LOT-010113 | Isopropyl Alcohol Variant 3 | rejected | Open workbench |
| LOT-010114 | Methylene Chloride Variant 3 | expired | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01352 Cartoning Machine #353 | operational | 2025-10-02 | qualified |
| AST-01353 Blister Packer #354 | in-calibration | 2024-10-01 | requalification-due |
| AST-01354 Shrink Wrapper #355 | in-maintenance | 2024-08-19 | not-qualified |
| AST-01355 Checkweigher #356 | out-of-service | 2025-02-02 | qualified |
| AST-01356 Metal Detector #357 | cleaning-required | 2024-07-22 | qualified |
| AST-01357 X-Ray Inspection #358 | operational | 2026-03-02 | qualified |
| AST-01358 Leak Tester #359 | operational | 2025-04-08 | requalification-due |
| AST-01359 Torque Tester #360 | operational | 2025-07-28 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | 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-020444
Score: 71
EBR completionOpen
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedComplete
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.