Batch BT-020275
Bioxalin SC • SGP • L026 • 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
2025-11-06 → 2025-11-17
Actual
2025-08-13 → 2026-10-01
Exceptions
10
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011925 | Hydroxypropyl Methylcellulose Variant 4 | in-process | Open workbench |
| LOT-011926 | Magnesium Stearate Variant 4 | approved | Open workbench |
| LOT-011927 | Croscarmellose Sodium Variant 4 | approved | Open workbench |
| LOT-011928 | Povidone K30 Variant 4 | approved | Open workbench |
| LOT-011929 | Talc Variant 4 | quarantine | Open workbench |
| LOT-011930 | Colloidal Silicon Dioxide Variant 4 | hold | Open workbench |
| LOT-011931 | Stearic Acid Variant 4 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01200 Granulator #201 | in-maintenance | 2026-09-10 | qualified |
| AST-01201 Tablet Press #202 | out-of-service | 2025-09-13 | qualified |
| AST-01202 Film Coater #203 | cleaning-required | 2025-02-15 | qualified |
| AST-01203 Capsule Filler #204 | operational | 2024-09-06 | requalification-due |
| AST-01204 Blender #205 | operational | 2026-06-23 | not-qualified |
| AST-01205 Autoclave #206 | operational | 2026-01-12 | qualified |
| AST-01206 Bioreactor #207 | in-calibration | 2026-08-01 | qualified |
| AST-01207 Centrifuge #208 | in-maintenance | 2025-10-24 | 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 | dev-01276 |
| 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.
Release Readiness: BT-020275
Score: 62
EBR completionOpen
Exceptions closedOpen
QC approvedOpen
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.