Batch BT-020591
Globustat • CMO2 • L042 • in-process
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
2026-11-15 → 2026-11-27
Actual
2024-01-23 → In progress
Exceptions
10
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011137 | Hydrochloric Acid 37% Variant 7 | quarantine | Open workbench |
| LOT-011138 | Sodium Hydroxide Variant 7 | hold | Open workbench |
| LOT-011139 | Phosphoric Acid Variant 7 | rejected | Open workbench |
| LOT-011140 | Active Pharmaceutical Ingredient A Variant 8 | expired | Open workbench |
| LOT-011141 | Active Pharmaceutical Ingredient B Variant 8 | consumed | Open workbench |
| LOT-011142 | Active Pharmaceutical Ingredient C Variant 8 | in-process | Open workbench |
| LOT-011143 | Microcrystalline Cellulose Variant 8 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01137 Friability Tester #138 | in-maintenance | 2025-06-23 | qualified |
| AST-01138 Particle Size Analyzer #139 | out-of-service | 2025-07-11 | requalification-due |
| AST-01139 Microscope #140 | cleaning-required | 2025-01-16 | not-qualified |
| AST-01140 Laminar Flow Cabinet #141 | operational | 2024-12-17 | qualified |
| AST-01141 Isolator #142 | operational | 2026-07-10 | qualified |
| AST-01142 WFI Still #143 | operational | 2026-05-24 | qualified |
| AST-01143 RO System #144 | in-calibration | 2024-12-26 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| System Error | major | under-review | Not linked |
| System Error | major | under-review | Not linked |
| System Error | major | under-review | Not linked |
| System Error | major | under-review | Not linked |
| System Error | major | under-review | Not linked |
| System Error | major | under-review | dev-01092 |
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.