Batch BT-020878
Pulmozide • CMO1 • L029 • rejected
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
2025-05-29 → 2025-06-11
Actual
2025-03-26 → 2026-03-05
Exceptions
19
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010512 | Active Pharmaceutical Ingredient C Variant 7 | in-process | Open workbench |
| LOT-010513 | Microcrystalline Cellulose Variant 7 | approved | Open workbench |
| LOT-010514 | Lactose Monohydrate Variant 7 | approved | Open workbench |
| LOT-010515 | Hydroxypropyl Methylcellulose Variant 7 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01224 Compressed Air System #225 | operational | 2025-04-20 | not-qualified |
| AST-01225 HVAC Unit #226 | operational | 2025-09-20 | qualified |
| AST-01226 Refrigerator #227 | operational | 2025-12-13 | qualified |
| AST-01227 Freezer Ultra-Low #228 | in-calibration | 2025-10-16 | qualified |
| AST-01228 Incubator #229 | in-maintenance | 2026-01-18 | requalification-due |
| AST-01229 Autoclave Sterilizer #230 | out-of-service | 2026-02-04 | not-qualified |
| AST-01230 Conveyor Belt #231 | cleaning-required | 2026-07-17 | qualified |
| AST-01231 Labeling Machine #232 | operational | 2026-03-16 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | dev-01379 |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | 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.