Batch BT-020501
Globustat • PPL • L002 • 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
2025-07-30 → 2025-08-07
Actual
2025-03-10 → In progress
Exceptions
7
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010006 | Magnesium Stearate | expired | Open workbench |
| LOT-010007 | Croscarmellose Sodium | consumed | Open workbench |
| LOT-010008 | Povidone K30 | in-process | Open workbench |
| LOT-010009 | Talc | approved | Open workbench |
| LOT-010010 | Colloidal Silicon Dioxide | approved | Open workbench |
| LOT-010011 | Stearic Acid | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01307 Freezer Ultra-Low #308 | cleaning-required | 2024-10-27 | qualified |
| AST-01308 Incubator #309 | operational | 2026-02-28 | requalification-due |
| AST-01309 Autoclave Sterilizer #310 | operational | 2024-09-10 | not-qualified |
| AST-01310 Conveyor Belt #311 | operational | 2026-02-22 | qualified |
| AST-01311 Labeling Machine #312 | in-calibration | 2025-01-14 | qualified |
| AST-01312 Cartoning Machine #313 | in-maintenance | 2025-05-11 | qualified |
| AST-01313 Blister Packer #314 | out-of-service | 2026-05-26 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | major | under-review | Not linked |
| Environmental Excursion | 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.
No release readiness record found.