Batch BT-020503
Vakrofen • CMO2 • L004 • completed
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
2026-10-10 → 2026-10-23
Actual
2024-02-04 → 2024-11-04
Exceptions
4
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011024 | Lactose Monohydrate Variant 4 | consumed | Open workbench |
| LOT-011025 | Hydroxypropyl Methylcellulose Variant 4 | in-process | Open workbench |
| LOT-011026 | Magnesium Stearate Variant 4 | approved | Open workbench |
| LOT-011027 | Croscarmellose Sodium Variant 4 | approved | Open workbench |
| LOT-011028 | Povidone K30 Variant 4 | approved | Open workbench |
| LOT-011029 | Talc Variant 4 | quarantine | Open workbench |
| LOT-011030 | Colloidal Silicon Dioxide Variant 4 | hold | Open workbench |
| LOT-011031 | Stearic Acid Variant 4 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01321 Tablet Press #322 | cleaning-required | 2025-04-30 | qualified |
| AST-01322 Film Coater #323 | operational | 2025-04-11 | qualified |
| AST-01323 Capsule Filler #324 | operational | 2025-10-01 | requalification-due |
| AST-01324 Blender #325 | operational | 2026-07-10 | not-qualified |
| AST-01325 Autoclave #326 | in-calibration | 2025-01-01 | qualified |
| AST-01326 Bioreactor #327 | in-maintenance | 2026-01-21 | qualified |
| AST-01327 Centrifuge #328 | out-of-service | 2025-04-18 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| System Error | major | closed | Not linked |
| System Error | major | closed | Not linked |
| System Error | major | closed | Not linked |
| System Error | major | closed | dev-00504 |
| System Error | major | closed | Not linked |
| System Error | major | closed | 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.