Batch BT-020136
Renalide Plus • NWK • L037 • released
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
2026-10-11 → 2026-10-15
Actual
2024-12-17 → 2025-07-04
Exceptions
18
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011224 | Methylene Chloride | approved | Open workbench |
| LOT-011225 | Acetonitrile HPLC Grade | approved | Open workbench |
| LOT-011226 | Methanol HPLC Grade | approved | Open workbench |
| LOT-011227 | Hydrochloric Acid 37% | quarantine | Open workbench |
| LOT-011228 | Sodium Hydroxide | hold | Open workbench |
| LOT-011229 | Phosphoric Acid | rejected | Open workbench |
| LOT-011230 | Active Pharmaceutical Ingredient A Variant 1 | expired | Open workbench |
| LOT-011231 | Active Pharmaceutical Ingredient B Variant 1 | consumed | Open workbench |
| LOT-011232 | Active Pharmaceutical Ingredient C Variant 1 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01144 Compressed Air System #145 | in-maintenance | 2026-08-24 | not-qualified |
| AST-01145 HVAC Unit #146 | out-of-service | 2025-04-06 | qualified |
| AST-01146 Refrigerator #147 | cleaning-required | 2025-06-15 | qualified |
| AST-01147 Freezer Ultra-Low #148 | operational | 2025-02-07 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Out of Specification | minor | under-review | Not linked |
| Out of Specification | minor | under-review | Not linked |
| Out of Specification | minor | under-review | Not linked |
| Out of Specification | minor | under-review | dev-00137 |
| Out of Specification | minor | under-review | dev-01137 |
| Out of Specification | minor | 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-020136
Score: 94
EBR completionOpen
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedOpen
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.