Batch BT-020508
Serathide • DUB • L009 • 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
2024-11-10 → 2024-11-18
Actual
2026-09-03 → 2024-03-14
Exceptions
0
Release Risk
high
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011064 | Polysorbate 80 Variant 5 | approved | Open workbench |
| LOT-011065 | Mannitol Variant 5 | quarantine | Open workbench |
| LOT-011066 | Sucrose Variant 5 | hold | Open workbench |
| LOT-011067 | Trehalose Variant 5 | rejected | Open workbench |
| LOT-011068 | Histidine Buffer Variant 5 | expired | Open workbench |
| LOT-011069 | Sodium Chloride Variant 5 | consumed | Open workbench |
| LOT-011070 | Water for Injection Variant 5 | in-process | Open workbench |
| LOT-011071 | Purified Water Variant 5 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| 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 |
| AST-01144 Compressed Air System #145 | in-maintenance | 2026-08-24 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | dev-00509 |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
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.
No release readiness record found.