Batch BT-020251
Nexipar SR • SGP • L002 • 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
2026-05-04 → 2026-05-08
Actual
2025-07-05 → In progress
Exceptions
13
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011757 | Trehalose Variant 8 | approved | Open workbench |
| LOT-011758 | Histidine Buffer Variant 8 | quarantine | Open workbench |
| LOT-011759 | Sodium Chloride Variant 8 | hold | Open workbench |
| LOT-011760 | Water for Injection Variant 8 | rejected | Open workbench |
| LOT-011761 | Purified Water Variant 8 | expired | Open workbench |
| LOT-011762 | Ethanol 95% Variant 8 | consumed | Open workbench |
| LOT-011763 | Isopropyl Alcohol Variant 8 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01055 Dissolution Tester #56 | cleaning-required | 2026-02-16 | qualified |
| AST-01056 Hardness Tester #57 | operational | 2026-03-10 | qualified |
| AST-01057 Friability Tester #58 | operational | 2024-12-14 | qualified |
| AST-01058 Particle Size Analyzer #59 | operational | 2025-08-28 | requalification-due |
| AST-01059 Microscope #60 | in-calibration | 2024-04-13 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Equipment Conflict | major | under-review | Not linked |
| Equipment Conflict | major | under-review | dev-01252 |
| Equipment Conflict | major | under-review | Not linked |
| Equipment Conflict | major | under-review | dev-00252 |
| Equipment Conflict | major | under-review | Not linked |
| Equipment Conflict | 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-020251
Score: 89
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.