Batch BT-020148
Serathide • DUB • L049 • 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
2024-05-14 → 2024-05-20
Actual
2026-04-02 → 2024-04-06
Exceptions
0
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010592 | Ethanol 95% Variant 9 | consumed | Open workbench |
| LOT-010593 | Isopropyl Alcohol Variant 9 | in-process | Open workbench |
| LOT-010594 | Methylene Chloride Variant 9 | approved | Open workbench |
| LOT-010595 | Acetonitrile HPLC Grade Variant 9 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01088 Lyophilizer #89 | in-maintenance | 2026-09-09 | requalification-due |
| AST-01089 Filling Machine #90 | out-of-service | 2025-11-07 | not-qualified |
| AST-01090 Visual Inspection System #91 | cleaning-required | 2026-09-15 | qualified |
| AST-01091 Weighing Balance #92 | operational | 2025-10-14 | qualified |
| AST-01092 HPLC System #93 | operational | 2026-06-30 | qualified |
| AST-01093 UV-Vis Spectrophotometer #94 | operational | 2025-04-29 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | minor | closed | dev-00149 |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | dev-00649 |
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-020148
Score: 96
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedOpen
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.