Batch BT-020250
Nexipar • BSL • L001 • 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
2025-11-18 → 2025-11-24
Actual
2025-07-10 → In progress
Exceptions
16
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012000 | Water for Injection Variant 6 | approved | Open workbench |
| LOT-012001 | Purified Water Variant 6 | quarantine | Open workbench |
| LOT-012002 | Ethanol 95% Variant 6 | hold | Open workbench |
| LOT-012003 | Isopropyl Alcohol Variant 6 | rejected | Open workbench |
| LOT-012004 | Methylene Chloride Variant 6 | expired | Open workbench |
| LOT-012005 | Acetonitrile HPLC Grade Variant 6 | consumed | Open workbench |
| LOT-012006 | Methanol HPLC Grade Variant 6 | in-process | Open workbench |
| LOT-012007 | Hydrochloric Acid 37% Variant 6 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01000 Granulator #1 | operational | 2025-09-25 | qualified |
| AST-01001 Tablet Press #2 | operational | 2024-08-06 | qualified |
| AST-01002 Film Coater #3 | operational | 2025-08-15 | qualified |
| AST-01003 Capsule Filler #4 | in-calibration | 2024-12-09 | requalification-due |
| AST-01004 Blender #5 | in-maintenance | 2024-05-29 | not-qualified |
| AST-01005 Autoclave #6 | out-of-service | 2025-07-22 | qualified |
| AST-01006 Bioreactor #7 | cleaning-required | 2024-12-27 | qualified |
| AST-01007 Centrifuge #8 | operational | 2025-09-28 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Late Step | critical | open | Not linked |
| Late Step | critical | open | Not linked |
| Late Step | critical | open | Not linked |
| Late Step | critical | open | Not linked |
| Late Step | critical | open | Not linked |
| Late Step | critical | open | 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-020250
Score: 82
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedOpen
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.