Batch BT-020438
Eptiveron HD • CMO1 • L039 • rejected
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
2024-01-22 → 2024-02-03
Actual
2025-03-23 → 2024-10-09
Exceptions
4
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011380 | Active Pharmaceutical Ingredient A Variant 6 | quarantine | Open workbench |
| LOT-011381 | Active Pharmaceutical Ingredient B Variant 6 | hold | Open workbench |
| LOT-011382 | Active Pharmaceutical Ingredient C Variant 6 | rejected | Open workbench |
| LOT-011383 | Microcrystalline Cellulose Variant 6 | expired | Open workbench |
| LOT-011384 | Lactose Monohydrate Variant 6 | consumed | Open workbench |
| LOT-011385 | Hydroxypropyl Methylcellulose Variant 6 | in-process | Open workbench |
| LOT-011386 | Magnesium Stearate Variant 6 | approved | Open workbench |
| LOT-011387 | Croscarmellose Sodium Variant 6 | approved | Open workbench |
| LOT-011388 | Povidone K30 Variant 6 | approved | Open workbench |
| LOT-011389 | Talc Variant 6 | quarantine | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01228 Incubator #229 | in-maintenance | 2026-01-18 | requalification-due |
| AST-01229 Autoclave Sterilizer #230 | out-of-service | 2026-02-04 | not-qualified |
| AST-01230 Conveyor Belt #231 | cleaning-required | 2026-07-17 | qualified |
| AST-01231 Labeling Machine #232 | operational | 2026-03-16 | qualified |
| AST-01232 Cartoning Machine #233 | operational | 2024-10-30 | qualified |
| AST-01233 Blister Packer #234 | operational | 2026-03-07 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | Not linked |
| Procedure Deviation | minor | closed | dev-00939 |
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-020438
Score: 96
EBR completionComplete
Exceptions closedOpen
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.