Batch BT-020643
Dermazol Forte • SGP • L044 • 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
2024-09-01 → 2024-09-11
Actual
2024-11-25 → 2026-11-18
Exceptions
13
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012572 | Ethanol 95% Variant 5 | consumed | Open workbench |
| LOT-012573 | Isopropyl Alcohol Variant 5 | in-process | Open workbench |
| LOT-012574 | Methylene Chloride Variant 5 | approved | Open workbench |
| LOT-012575 | Acetonitrile HPLC Grade Variant 5 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01101 Isolator #102 | in-calibration | 2024-07-18 | qualified |
| AST-01102 WFI Still #103 | in-maintenance | 2025-12-13 | qualified |
| AST-01103 RO System #104 | out-of-service | 2025-09-05 | requalification-due |
| AST-01104 Compressed Air System #105 | cleaning-required | 2025-03-16 | not-qualified |
| AST-01105 HVAC Unit #106 | operational | 2025-02-26 | qualified |
| AST-01106 Refrigerator #107 | operational | 2025-06-01 | qualified |
| AST-01107 Freezer Ultra-Low #108 | operational | 2026-02-09 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Equipment Conflict | major | closed | Not linked |
| Equipment Conflict | major | closed | Not linked |
| Equipment Conflict | major | closed | Not linked |
| Equipment Conflict | major | closed | Not linked |
| Equipment Conflict | major | closed | Not linked |
| Equipment Conflict | 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.