Batch BT-020825
Renalide • DRH • L026 • 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
2026-01-11 → 2026-01-22
Actual
2025-06-30 → 2026-10-18
Exceptions
22
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012775 | Mannitol Variant 2 | quarantine | Open workbench |
| LOT-012776 | Sucrose Variant 2 | hold | Open workbench |
| LOT-012777 | Trehalose Variant 2 | rejected | Open workbench |
| LOT-012778 | Histidine Buffer Variant 2 | expired | Open workbench |
| LOT-012779 | Sodium Chloride Variant 2 | consumed | Open workbench |
| LOT-012780 | Water for Injection Variant 2 | in-process | Open workbench |
| LOT-012781 | Purified Water Variant 2 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01200 Granulator #201 | in-maintenance | 2026-09-10 | qualified |
| AST-01201 Tablet Press #202 | out-of-service | 2025-09-13 | qualified |
| AST-01202 Film Coater #203 | cleaning-required | 2025-02-15 | qualified |
| AST-01203 Capsule Filler #204 | operational | 2024-09-06 | requalification-due |
| AST-01204 Blender #205 | operational | 2026-06-23 | not-qualified |
| AST-01205 Autoclave #206 | operational | 2026-01-12 | qualified |
| AST-01206 Bioreactor #207 | in-calibration | 2026-08-01 | qualified |
| AST-01207 Centrifuge #208 | in-maintenance | 2025-10-24 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | 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.
No release readiness record found.