Batch BT-020661
Veranide XR • PPL • L012 • in-process
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
2025-02-08 → 2025-02-14
Actual
2024-11-27 → In progress
Exceptions
18
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010305 | Hydroxypropyl Methylcellulose | in-process | Open workbench |
| LOT-010306 | Magnesium Stearate | approved | Open workbench |
| LOT-010307 | Croscarmellose Sodium | approved | Open workbench |
| LOT-010308 | Povidone K30 | approved | Open workbench |
| LOT-010309 | Talc | quarantine | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01227 Freezer Ultra-Low #228 | in-calibration | 2025-10-16 | qualified |
| AST-01228 Incubator #229 | in-maintenance | 2026-01-18 | requalification-due |
| AST-01229 Autoclave Sterilizer #230 | out-of-service | 2026-02-04 | not-qualified |
| AST-01230 Conveyor Belt #231 | cleaning-required | 2026-07-17 | qualified |
| AST-01231 Labeling Machine #232 | operational | 2026-03-16 | qualified |
| AST-01232 Cartoning Machine #233 | operational | 2024-10-30 | qualified |
| AST-01233 Blister Packer #234 | operational | 2026-03-07 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | dev-01162 |
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.