Batch BT-020821
Nexipar SR • PPL • L022 • 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
2024-09-22 → 2024-10-01
Actual
2025-12-19 → In progress
Exceptions
12
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| 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-01084 Blender #85 | operational | 2025-11-14 | not-qualified |
| AST-01085 Autoclave #86 | operational | 2025-05-11 | qualified |
| AST-01086 Bioreactor #87 | operational | 2024-09-24 | qualified |
| AST-01087 Centrifuge #88 | in-calibration | 2026-06-09 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | major | under-review | dev-00822 |
| 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 |
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.