Batch BT-020311
Nexipar SR • CMO2 • L012 • 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
2026-04-28 → 2026-05-03
Actual
2025-02-11 → In progress
Exceptions
5
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012488 | Sodium Hydroxide Variant 2 | hold | Open workbench |
| LOT-012489 | Phosphoric Acid Variant 2 | rejected | Open workbench |
| LOT-012490 | Active Pharmaceutical Ingredient A Variant 3 | expired | Open workbench |
| LOT-012491 | Active Pharmaceutical Ingredient B Variant 3 | consumed | Open workbench |
| LOT-012492 | Active Pharmaceutical Ingredient C Variant 3 | in-process | Open workbench |
| LOT-012493 | Microcrystalline Cellulose Variant 3 | approved | Open workbench |
| LOT-012494 | Lactose Monohydrate Variant 3 | approved | Open workbench |
| LOT-012495 | Hydroxypropyl Methylcellulose Variant 3 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01266 Refrigerator #267 | operational | 2025-01-08 | qualified |
| AST-01267 Freezer Ultra-Low #268 | operational | 2026-04-07 | qualified |
| AST-01268 Incubator #269 | operational | 2025-03-08 | requalification-due |
| AST-01269 Autoclave Sterilizer #270 | in-calibration | 2025-12-25 | not-qualified |
| AST-01270 Conveyor Belt #271 | in-maintenance | 2026-08-30 | qualified |
| AST-01271 Labeling Machine #272 | out-of-service | 2025-08-17 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
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-020311
Score: 71
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.