Batch BT-020105
Renalide • DRH • L006 • 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
2026-10-08 → 2026-10-19
Actual
2026-03-22 → 2026-08-12
Exceptions
24
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010525 | Mannitol Variant 7 | quarantine | Open workbench |
| LOT-010526 | Sucrose Variant 7 | hold | Open workbench |
| LOT-010527 | Trehalose Variant 7 | rejected | Open workbench |
| LOT-010528 | Histidine Buffer Variant 7 | expired | Open workbench |
| LOT-010529 | Sodium Chloride Variant 7 | consumed | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01040 Granulator #41 | out-of-service | 2024-12-15 | qualified |
| AST-01041 Tablet Press #42 | cleaning-required | 2025-08-03 | qualified |
| AST-01042 Film Coater #43 | operational | 2024-05-23 | qualified |
| AST-01043 Capsule Filler #44 | operational | 2026-01-03 | requalification-due |
| AST-01044 Blender #45 | operational | 2025-10-02 | not-qualified |
| AST-01045 Autoclave #46 | in-calibration | 2025-10-23 | qualified |
| AST-01046 Bioreactor #47 | in-maintenance | 2025-07-26 | qualified |
| AST-01047 Centrifuge #48 | out-of-service | 2026-01-16 | 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 | dev-00106 |
| 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.
Release Readiness: BT-020105
Score: 100
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.