Batch BT-020433
Dermazol Forte • DRH • L034 • 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
2024-02-01 → 2024-02-14
Actual
2025-08-12 → 2025-12-06
Exceptions
12
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011732 | Ethanol 95% Variant 7 | hold | Open workbench |
| LOT-011733 | Isopropyl Alcohol Variant 7 | rejected | Open workbench |
| LOT-011734 | Methylene Chloride Variant 7 | expired | Open workbench |
| LOT-011735 | Acetonitrile HPLC Grade Variant 7 | consumed | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01231 Labeling Machine #232 | operational | 2026-03-16 | qualified |
| AST-01232 Cartoning Machine #233 | operational | 2024-10-30 | qualified |
| AST-01233 Blister Packer #234 | operational | 2026-03-07 | requalification-due |
| AST-01234 Shrink Wrapper #235 | in-calibration | 2025-09-11 | not-qualified |
| 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 |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | major | closed | Not linked |
| Missing Signature | major | closed | Not linked |
| Missing Signature | major | closed | dev-00934 |
| Missing Signature | major | closed | Not linked |
| Missing Signature | major | closed | Not linked |
| Missing Signature | 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.
Release Readiness: BT-020433
Score: 62
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.