Batch BT-020665
Bioxalin SC • DRH • L016 • 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
2024-05-23 → 2024-06-06
Actual
2026-07-16 → 2024-02-21
Exceptions
21
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011655 | Hydroxypropyl Methylcellulose Variant 5 | in-process | Open workbench |
| LOT-011656 | Magnesium Stearate Variant 5 | approved | Open workbench |
| LOT-011657 | Croscarmellose Sodium Variant 5 | approved | Open workbench |
| LOT-011658 | Povidone K30 Variant 5 | approved | Open workbench |
| LOT-011659 | Talc Variant 5 | quarantine | Open workbench |
| LOT-011660 | Colloidal Silicon Dioxide Variant 5 | hold | Open workbench |
| LOT-011661 | Stearic Acid Variant 5 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01130 Visual Inspection System #131 | in-maintenance | 2025-09-14 | qualified |
| AST-01131 Weighing Balance #132 | out-of-service | 2026-02-22 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | open | dev-00166 |
| Missing Signature | minor | open | 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.