Batch BT-020767
Eptiveron • CMO2 • L018 • 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
2024-01-19 → 2024-01-29
Actual
2025-07-29 → In progress
Exceptions
4
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010903 | Microcrystalline Cellulose | quarantine | Open workbench |
| LOT-010904 | Lactose Monohydrate | hold | Open workbench |
| LOT-010905 | Hydroxypropyl Methylcellulose | rejected | Open workbench |
| LOT-010906 | Magnesium Stearate | expired | Open workbench |
| LOT-010907 | Croscarmellose Sodium | consumed | Open workbench |
| LOT-010908 | Povidone K30 | in-process | Open workbench |
| LOT-010909 | Talc | approved | Open workbench |
| LOT-010910 | Colloidal Silicon Dioxide | approved | Open workbench |
| LOT-010911 | Stearic Acid | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01235 Checkweigher #236 | in-maintenance | 2024-12-07 | qualified |
| AST-01236 Metal Detector #237 | out-of-service | 2026-05-30 | qualified |
| AST-01237 X-Ray Inspection #238 | cleaning-required | 2025-01-14 | qualified |
| AST-01238 Leak Tester #239 | operational | 2025-12-30 | requalification-due |
| AST-01239 Torque Tester #240 | operational | 2025-12-31 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| System Error | minor | under-review | Not linked |
| System Error | minor | under-review | Not linked |
| System Error | minor | under-review | Not linked |
| System Error | minor | under-review | Not linked |
| System Error | minor | under-review | Not linked |
| System Error | 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.