Batch BT-020441
Globustat • DRH • 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
2026-08-15 → 2026-08-18
Actual
2026-07-27 → In progress
Exceptions
23
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010969 | Talc Variant 2 | expired | Open workbench |
| LOT-010970 | Colloidal Silicon Dioxide Variant 2 | consumed | Open workbench |
| LOT-010971 | Stearic Acid Variant 2 | in-process | Open workbench |
| LOT-010972 | Titanium Dioxide Variant 2 | approved | Open workbench |
| LOT-010973 | Polyethylene Glycol 400 Variant 2 | approved | Open workbench |
| LOT-010974 | Polysorbate 80 Variant 2 | approved | Open workbench |
| LOT-010975 | Mannitol Variant 2 | quarantine | Open workbench |
| LOT-010976 | Sucrose Variant 2 | hold | Open workbench |
| LOT-010977 | Trehalose Variant 2 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01205 Autoclave #206 | operational | 2026-01-12 | qualified |
| AST-01206 Bioreactor #207 | in-calibration | 2026-08-01 | qualified |
| AST-01207 Centrifuge #208 | in-maintenance | 2025-10-24 | qualified |
| AST-01208 Lyophilizer #209 | out-of-service | 2025-11-29 | requalification-due |
| AST-01209 Filling Machine #210 | cleaning-required | 2025-06-11 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | major | under-review | dev-00442 |
| Missing Signature | major | under-review | dev-01442 |
| Missing Signature | major | under-review | Not linked |
| Missing Signature | major | under-review | Not linked |
| Missing Signature | major | under-review | Not linked |
| Missing Signature | major | under-review | 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-020441
Score: 61
EBR completionOpen
Exceptions closedComplete
QC approvedComplete
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.