Batch BT-020389
Vaccelox • PPL • L040 • planned
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
2026-07-12 → 2026-07-24
Actual
Pending → In progress
Exceptions
13
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012723 | Isopropyl Alcohol | rejected | Open workbench |
| LOT-012724 | Methylene Chloride | expired | Open workbench |
| LOT-012725 | Acetonitrile HPLC Grade | consumed | Open workbench |
| LOT-012726 | Methanol HPLC Grade | in-process | Open workbench |
| LOT-012727 | Hydrochloric Acid 37% | approved | Open workbench |
| LOT-012728 | Sodium Hydroxide | approved | Open workbench |
| LOT-012729 | Phosphoric Acid | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01312 Cartoning Machine #313 | in-maintenance | 2025-05-11 | qualified |
| AST-01313 Blister Packer #314 | out-of-service | 2026-05-26 | requalification-due |
| AST-01314 Shrink Wrapper #315 | cleaning-required | 2024-10-05 | not-qualified |
| AST-01315 Checkweigher #316 | operational | 2024-12-28 | qualified |
| AST-01316 Metal Detector #317 | operational | 2026-01-11 | qualified |
| AST-01317 X-Ray Inspection #318 | operational | 2025-07-19 | qualified |
| AST-01318 Leak Tester #319 | in-calibration | 2026-02-08 | requalification-due |
| AST-01319 Torque Tester #320 | in-maintenance | 2026-03-01 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | minor | closed | dev-00390 |
| Environmental Excursion | minor | closed | Not linked |
| Environmental Excursion | minor | closed | dev-00890 |
| Environmental Excursion | minor | closed | Not linked |
| Environmental Excursion | minor | closed | Not linked |
| Environmental Excursion | 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-020389
Score: 100
EBR completionComplete
Exceptions closedOpen
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.