Batch BT-020461
Nexipar SR • PPL • 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
2024-06-09 → 2024-06-17
Actual
2026-09-10 → In progress
Exceptions
21
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012305 | Acetonitrile HPLC Grade Variant 6 | approved | Open workbench |
| LOT-012306 | Methanol HPLC Grade Variant 6 | approved | Open workbench |
| LOT-012307 | Hydrochloric Acid 37% Variant 6 | quarantine | Open workbench |
| LOT-012308 | Sodium Hydroxide Variant 6 | hold | Open workbench |
| LOT-012309 | Phosphoric Acid Variant 6 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01244 Blender #245 | cleaning-required | 2026-04-06 | not-qualified |
| AST-01245 Autoclave #246 | operational | 2026-09-16 | qualified |
| AST-01246 Bioreactor #247 | operational | 2025-09-11 | qualified |
| AST-01247 Centrifuge #248 | operational | 2026-02-10 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| 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 |
| Environmental Excursion | major | under-review | dev-00962 |
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-020461
Score: 81
EBR completionOpen
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedComplete
Calibration compliantOpen
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.