Batch BT-020897
Mentreva • DRH • L048 • on-hold
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
2026-06-25 → 2026-07-06
Actual
2024-07-04 → In progress
Exceptions
12
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011176 | Magnesium Stearate Variant 9 | expired | Open workbench |
| LOT-011177 | Croscarmellose Sodium Variant 9 | consumed | Open workbench |
| LOT-011178 | Povidone K30 Variant 9 | in-process | Open workbench |
| LOT-011179 | Talc Variant 9 | approved | Open workbench |
| LOT-011180 | Colloidal Silicon Dioxide Variant 9 | approved | Open workbench |
| LOT-011181 | Stearic Acid Variant 9 | approved | Open workbench |
| LOT-011182 | Titanium Dioxide Variant 9 | quarantine | Open workbench |
| LOT-011183 | Polyethylene Glycol 400 Variant 9 | hold | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01279 Torque Tester #280 | cleaning-required | 2025-11-04 | not-qualified |
| 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 |
| AST-01285 Autoclave #286 | out-of-service | 2026-03-02 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | dev-00898 |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | 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.
No release readiness record found.