Batch BT-020297
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
2026-08-16 → 2026-08-26
Actual
2026-09-07 → In progress
Exceptions
22
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012673 | Microcrystalline Cellulose Variant 9 | approved | Open workbench |
| LOT-012674 | Lactose Monohydrate Variant 9 | approved | Open workbench |
| LOT-012675 | Hydroxypropyl Methylcellulose Variant 9 | approved | Open workbench |
| LOT-012676 | Magnesium Stearate Variant 9 | quarantine | Open workbench |
| LOT-012677 | Croscarmellose Sodium Variant 9 | hold | Open workbench |
| LOT-012678 | Povidone K30 Variant 9 | rejected | Open workbench |
| LOT-012679 | Talc Variant 9 | expired | Open workbench |
| LOT-012680 | Colloidal Silicon Dioxide Variant 9 | consumed | Open workbench |
| LOT-012681 | Stearic Acid Variant 9 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01079 Torque Tester #80 | operational | 2026-02-22 | not-qualified |
| AST-01080 Granulator #81 | in-calibration | 2025-12-31 | qualified |
| AST-01081 Tablet Press #82 | in-maintenance | 2024-12-18 | qualified |
| AST-01082 Film Coater #83 | out-of-service | 2025-07-29 | qualified |
| AST-01083 Capsule Filler #84 | cleaning-required | 2025-04-29 | requalification-due |
| AST-01084 Blender #85 | operational | 2025-11-14 | not-qualified |
| AST-01085 Autoclave #86 | operational | 2025-05-11 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | minor | under-review | dev-00298 |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | dev-00298 |
| 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.
Release Readiness: BT-020297
Score: 76
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.