Batch BT-020281
Nexipar SR • DRH • L032 • 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
2025-02-24 → 2025-03-09
Actual
2026-02-27 → In progress
Exceptions
21
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011124 | Polysorbate 80 Variant 7 | in-process | Open workbench |
| LOT-011125 | Mannitol Variant 7 | approved | Open workbench |
| LOT-011126 | Sucrose Variant 7 | approved | Open workbench |
| LOT-011127 | Trehalose Variant 7 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01086 Bioreactor #87 | operational | 2024-09-24 | qualified |
| AST-01087 Centrifuge #88 | in-calibration | 2026-06-09 | qualified |
| AST-01088 Lyophilizer #89 | in-maintenance | 2026-09-09 | requalification-due |
| AST-01089 Filling Machine #90 | out-of-service | 2025-11-07 | not-qualified |
| AST-01090 Visual Inspection System #91 | cleaning-required | 2026-09-15 | qualified |
| AST-01091 Weighing Balance #92 | operational | 2025-10-14 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | major | under-review | Not linked |
| Missing Signature | major | under-review | dev-01282 |
| Missing Signature | major | under-review | Not linked |
| Missing Signature | major | under-review | Not linked |
| Missing Signature | major | under-review | dev-01282 |
| 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.
Release Readiness: BT-020281
Score: 65
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
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.