Batch BT-020437
Eptiveron • PPL • L038 • on-hold
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
2026-08-13 → 2026-08-27
Actual
2026-02-15 → In progress
Exceptions
13
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010059 | Phosphoric Acid Variant 1 | rejected | Open workbench |
| LOT-010060 | Active Pharmaceutical Ingredient A Variant 2 | expired | Open workbench |
| LOT-010061 | Active Pharmaceutical Ingredient B Variant 2 | consumed | Open workbench |
| LOT-010062 | Active Pharmaceutical Ingredient C Variant 2 | in-process | Open workbench |
| LOT-010063 | Microcrystalline Cellulose Variant 2 | approved | Open workbench |
| LOT-010064 | Lactose Monohydrate Variant 2 | approved | Open workbench |
| LOT-010065 | Hydroxypropyl Methylcellulose Variant 2 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01185 HVAC Unit #186 | in-calibration | 2025-10-03 | qualified |
| AST-01186 Refrigerator #187 | in-maintenance | 2026-07-11 | qualified |
| AST-01187 Freezer Ultra-Low #188 | out-of-service | 2026-01-04 | qualified |
| AST-01188 Incubator #189 | cleaning-required | 2025-04-29 | requalification-due |
| AST-01189 Autoclave Sterilizer #190 | operational | 2025-04-13 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | minor | under-review | dev-00438 |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | dev-00938 |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | dev-01438 |
| Environmental Excursion | minor | 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-020437
Score: 60
EBR completionComplete
Exceptions closedOpen
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.