Batch BT-020515
Bioxalin SC • SGP • 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
2024-01-13 → 2024-01-21
Actual
2024-06-02 → 2026-01-17
Exceptions
21
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010090 | Active Pharmaceutical Ingredient A Variant 3 | approved | Open workbench |
| LOT-010091 | Active Pharmaceutical Ingredient B Variant 3 | approved | Open workbench |
| LOT-010092 | Active Pharmaceutical Ingredient C Variant 3 | approved | Open workbench |
| LOT-010093 | Microcrystalline Cellulose Variant 3 | quarantine | Open workbench |
| LOT-010094 | Lactose Monohydrate Variant 3 | hold | Open workbench |
| LOT-010095 | Hydroxypropyl Methylcellulose Variant 3 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01175 Dissolution Tester #176 | operational | 2024-11-26 | qualified |
| AST-01176 Hardness Tester #177 | operational | 2025-02-14 | qualified |
| AST-01177 Friability Tester #178 | operational | 2025-01-10 | qualified |
| AST-01178 Particle Size Analyzer #179 | in-calibration | 2025-07-27 | requalification-due |
| AST-01179 Microscope #180 | in-maintenance | 2024-12-17 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Equipment Conflict | minor | open | Not linked |
| Equipment Conflict | minor | open | Not linked |
| Equipment Conflict | minor | open | Not linked |
| Equipment Conflict | minor | open | Not linked |
| Equipment Conflict | minor | open | Not linked |
| Equipment Conflict | 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.