Batch BT-020413
Vakrofen • PPL • L014 • 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
2025-10-31 → 2025-11-03
Actual
2025-05-17 → 2026-07-22
Exceptions
12
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011652 | Active Pharmaceutical Ingredient C Variant 5 | rejected | Open workbench |
| LOT-011653 | Microcrystalline Cellulose Variant 5 | expired | Open workbench |
| LOT-011654 | Lactose Monohydrate Variant 5 | consumed | Open workbench |
| LOT-011655 | Hydroxypropyl Methylcellulose Variant 5 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01104 Compressed Air System #105 | cleaning-required | 2025-03-16 | not-qualified |
| AST-01105 HVAC Unit #106 | operational | 2025-02-26 | qualified |
| AST-01106 Refrigerator #107 | operational | 2025-06-01 | qualified |
| AST-01107 Freezer Ultra-Low #108 | operational | 2026-02-09 | qualified |
| AST-01108 Incubator #109 | in-calibration | 2025-09-02 | requalification-due |
| AST-01109 Autoclave Sterilizer #110 | in-maintenance | 2026-07-20 | not-qualified |
| AST-01110 Conveyor Belt #111 | out-of-service | 2025-10-12 | qualified |
| AST-01111 Labeling Machine #112 | cleaning-required | 2025-12-10 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | major | closed | dev-00414 |
| Environmental Excursion | major | closed | Not linked |
| Environmental Excursion | major | closed | dev-00914 |
| Environmental Excursion | major | closed | Not linked |
| Environmental Excursion | major | closed | dev-01414 |
| Environmental Excursion | major | 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-020413
Score: 87
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.