Batch BT-020168
Eptiveron HD • NWK • L019 • 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
2024-11-13 → 2024-11-25
Actual
2026-03-01 → 2025-07-18
Exceptions
23
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011008 | Histidine Buffer Variant 3 | approved | Open workbench |
| LOT-011009 | Sodium Chloride Variant 3 | approved | Open workbench |
| LOT-011010 | Water for Injection Variant 3 | approved | Open workbench |
| LOT-011011 | Purified Water Variant 3 | quarantine | Open workbench |
| LOT-011012 | Ethanol 95% Variant 3 | hold | Open workbench |
| LOT-011013 | Isopropyl Alcohol Variant 3 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01040 Granulator #41 | out-of-service | 2024-12-15 | qualified |
| AST-01041 Tablet Press #42 | cleaning-required | 2025-08-03 | qualified |
| AST-01042 Film Coater #43 | operational | 2024-05-23 | qualified |
| AST-01043 Capsule Filler #44 | operational | 2026-01-03 | requalification-due |
| AST-01044 Blender #45 | operational | 2025-10-02 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | dev-00169 |
| Out of Specification | minor | closed | dev-01169 |
| Out of Specification | minor | closed | dev-00669 |
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-020168
Score: 70
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.