Batch BT-020822
Dermazol • CMO1 • L023 • 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
2025-05-14 → 2025-05-19
Actual
2026-04-24 → 2024-03-28
Exceptions
18
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012220 | Active Pharmaceutical Ingredient A Variant 4 | expired | Open workbench |
| LOT-012221 | Active Pharmaceutical Ingredient B Variant 4 | consumed | Open workbench |
| LOT-012222 | Active Pharmaceutical Ingredient C Variant 4 | in-process | Open workbench |
| LOT-012223 | Microcrystalline Cellulose Variant 4 | approved | Open workbench |
| LOT-012224 | Lactose Monohydrate Variant 4 | approved | Open workbench |
| LOT-012225 | Hydroxypropyl Methylcellulose Variant 4 | approved | Open workbench |
| LOT-012226 | Magnesium Stearate Variant 4 | quarantine | Open workbench |
| LOT-012227 | Croscarmellose Sodium Variant 4 | hold | Open workbench |
| LOT-012228 | Povidone K30 Variant 4 | rejected | Open workbench |
| LOT-012229 | Talc Variant 4 | expired | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01132 HPLC System #133 | cleaning-required | 2026-03-27 | qualified |
| AST-01133 UV-Vis Spectrophotometer #134 | operational | 2026-05-23 | requalification-due |
| AST-01134 Karl Fischer Titrator #135 | operational | 2025-06-28 | not-qualified |
| AST-01135 Dissolution Tester #136 | operational | 2026-03-20 | qualified |
| AST-01136 Hardness Tester #137 | in-calibration | 2025-03-19 | qualified |
| AST-01137 Friability Tester #138 | in-maintenance | 2025-06-23 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | major | under-review | dev-00823 |
| Procedure Deviation | major | under-review | dev-00323 |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | dev-01323 |
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.