Batch BT-020886
Renalide Plus • CMO1 • 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
2025-09-08 → 2025-09-21
Actual
2025-05-28 → 2026-11-02
Exceptions
21
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012316 | Magnesium Stearate Variant 7 | quarantine | Open workbench |
| LOT-012317 | Croscarmellose Sodium Variant 7 | hold | Open workbench |
| LOT-012318 | Povidone K30 Variant 7 | rejected | Open workbench |
| LOT-012319 | Talc Variant 7 | expired | Open workbench |
| LOT-012320 | Colloidal Silicon Dioxide Variant 7 | consumed | Open workbench |
| LOT-012321 | Stearic Acid Variant 7 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01344 Compressed Air System #345 | operational | 2025-05-15 | not-qualified |
| AST-01345 HVAC Unit #346 | operational | 2026-03-28 | qualified |
| AST-01346 Refrigerator #347 | in-calibration | 2025-11-24 | qualified |
| AST-01347 Freezer Ultra-Low #348 | in-maintenance | 2026-05-07 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | minor | under-review | Not linked |
| Procedure Deviation | minor | under-review | Not linked |
| Procedure Deviation | minor | under-review | Not linked |
| Procedure Deviation | minor | under-review | Not linked |
| Procedure Deviation | minor | under-review | Not linked |
| Procedure Deviation | minor | under-review | dev-01387 |
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.
No release readiness record found.