Batch BT-020376
Renalide Plus • NWK • L027 • 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
2024-05-18 → 2024-05-25
Actual
2025-09-07 → 2026-10-12
Exceptions
2
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011128 | Histidine Buffer Variant 7 | quarantine | Open workbench |
| LOT-011129 | Sodium Chloride Variant 7 | hold | Open workbench |
| LOT-011130 | Water for Injection Variant 7 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01280 Granulator #281 | operational | 2025-07-18 | qualified |
| AST-01281 Tablet Press #282 | operational | 2025-12-22 | qualified |
| AST-01282 Film Coater #283 | operational | 2025-09-17 | qualified |
| AST-01283 Capsule Filler #284 | in-calibration | 2024-09-29 | requalification-due |
| AST-01284 Blender #285 | in-maintenance | 2026-12-02 | not-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 | Not linked |
| Out of Specification | minor | under-review | Not linked |
| Out of Specification | minor | under-review | dev-00877 |
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-020376
Score: 67
EBR completionComplete
Exceptions closedOpen
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.