Batch BT-020467
Eptiveron • SGP • 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
2024-02-21 → 2024-02-28
Actual
2024-09-03 → In progress
Exceptions
9
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011203 | Microcrystalline Cellulose | expired | Open workbench |
| LOT-011204 | Lactose Monohydrate | consumed | Open workbench |
| LOT-011205 | Hydroxypropyl Methylcellulose | in-process | Open workbench |
| LOT-011206 | Magnesium Stearate | approved | Open workbench |
| LOT-011207 | Croscarmellose Sodium | approved | Open workbench |
| LOT-011208 | Povidone K30 | approved | Open workbench |
| LOT-011209 | Talc | quarantine | Open workbench |
| LOT-011210 | Colloidal Silicon Dioxide | hold | Open workbench |
| LOT-011211 | Stearic Acid | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01268 Incubator #269 | operational | 2025-03-08 | requalification-due |
| AST-01269 Autoclave Sterilizer #270 | in-calibration | 2025-12-25 | not-qualified |
| AST-01270 Conveyor Belt #271 | in-maintenance | 2026-08-30 | qualified |
| AST-01271 Labeling Machine #272 | out-of-service | 2025-08-17 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Equipment Conflict | minor | under-review | Not linked |
| Equipment Conflict | minor | under-review | dev-01468 |
| Equipment Conflict | minor | under-review | dev-00968 |
| Equipment Conflict | minor | under-review | Not linked |
| Equipment Conflict | minor | under-review | Not linked |
| Equipment Conflict | minor | under-review | dev-00968 |
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-020467
Score: 97
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.