Batch BT-020422
Celdurin • CMO1 • L023 • completed
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
2025-05-18 → 2025-05-26
Actual
2025-09-24 → 2025-08-11
Exceptions
22
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012110 | Colloidal Silicon Dioxide | hold | Open workbench |
| LOT-012111 | Stearic Acid | rejected | Open workbench |
| LOT-012112 | Titanium Dioxide | expired | Open workbench |
| LOT-012113 | Polyethylene Glycol 400 | consumed | Open workbench |
| LOT-012114 | Polysorbate 80 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01176 Hardness Tester #177 | operational | 2025-02-14 | qualified |
| AST-01177 Friability Tester #178 | operational | 2025-01-10 | qualified |
| AST-01178 Particle Size Analyzer #179 | in-calibration | 2025-07-27 | requalification-due |
| AST-01179 Microscope #180 | in-maintenance | 2024-12-17 | not-qualified |
| AST-01180 Laminar Flow Cabinet #181 | out-of-service | 2026-05-03 | qualified |
| AST-01181 Isolator #182 | cleaning-required | 2026-04-04 | qualified |
| AST-01182 WFI Still #183 | operational | 2025-09-12 | qualified |
| AST-01183 RO System #184 | operational | 2025-07-02 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | dev-00423 |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | 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.
Release Readiness: BT-020422
Score: 74
EBR completionOpen
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedComplete
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.