Batch BT-020317
Eptiveron • PPL • L018 • 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
2026-12-16 → 2026-12-29
Actual
2024-07-08 → In progress
Exceptions
16
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012219 | Phosphoric Acid Variant 3 | rejected | Open workbench |
| LOT-012220 | Active Pharmaceutical Ingredient A Variant 4 | expired | Open workbench |
| LOT-012221 | Active Pharmaceutical Ingredient B Variant 4 | consumed | Open workbench |
| LOT-012222 | Active Pharmaceutical Ingredient C Variant 4 | in-process | Open workbench |
| LOT-012223 | Microcrystalline Cellulose Variant 4 | approved | Open workbench |
| LOT-012224 | Lactose Monohydrate Variant 4 | approved | Open workbench |
| LOT-012225 | Hydroxypropyl Methylcellulose Variant 4 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01136 Hardness Tester #137 | in-calibration | 2025-03-19 | qualified |
| 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 |
|---|---|---|---|
| Environmental Excursion | minor | under-review | dev-00318 |
| Environmental Excursion | minor | under-review | dev-01318 |
| Environmental Excursion | minor | under-review | dev-00818 |
| Environmental Excursion | minor | under-review | dev-00318 |
| Environmental Excursion | minor | under-review | Not linked |
| Environmental Excursion | minor | under-review | dev-00818 |
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-020317
Score: 67
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
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.