Batch BT-020961
Veranide XR • DRH • 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
2024-06-20 → 2024-06-23
Actual
2024-07-29 → In progress
Exceptions
12
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012883 | Microcrystalline Cellulose Variant 6 | quarantine | Open workbench |
| LOT-012884 | Lactose Monohydrate Variant 6 | hold | Open workbench |
| LOT-012885 | Hydroxypropyl Methylcellulose Variant 6 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01327 Centrifuge #328 | out-of-service | 2025-04-18 | qualified |
| AST-01328 Lyophilizer #329 | cleaning-required | 2025-07-09 | requalification-due |
| AST-01329 Filling Machine #330 | operational | 2026-03-08 | not-qualified |
| AST-01330 Visual Inspection System #331 | operational | 2025-10-19 | qualified |
| AST-01331 Weighing Balance #332 | operational | 2026-05-18 | qualified |
| AST-01332 HPLC System #333 | in-calibration | 2025-06-06 | qualified |
| AST-01333 UV-Vis Spectrophotometer #334 | in-maintenance | 2025-07-12 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | major | under-review | dev-00962 |
| Missing Signature | major | under-review | dev-00462 |
| Missing Signature | major | under-review | Not linked |
| Missing Signature | major | under-review | Not linked |
| Missing Signature | major | under-review | Not linked |
| Missing Signature | major | under-review | 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.
No release readiness record found.