Batch BT-020103
Dermazol Forte • 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
2024-04-29 → 2024-05-02
Actual
2025-10-26 → 2026-10-30
Exceptions
25
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010721 | Active Pharmaceutical Ingredient B Variant 4 | approved | Open workbench |
| LOT-010722 | Active Pharmaceutical Ingredient C Variant 4 | approved | Open workbench |
| LOT-010723 | Microcrystalline Cellulose Variant 4 | quarantine | Open workbench |
| LOT-010724 | Lactose Monohydrate Variant 4 | hold | Open workbench |
| LOT-010725 | Hydroxypropyl Methylcellulose Variant 4 | rejected | Open workbench |
| LOT-010726 | Magnesium Stearate Variant 4 | expired | Open workbench |
| LOT-010727 | Croscarmellose Sodium Variant 4 | consumed | 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 |
|---|
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-020103
Score: 73
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedComplete
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.