Batch BT-020302
Celdurin • CMO1 • L003 • 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
2024-01-21 → 2024-01-30
Actual
2024-08-28 → 2024-01-22
Exceptions
11
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011208 | Povidone K30 | approved | Open workbench |
| LOT-011209 | Talc | quarantine | Open workbench |
| LOT-011210 | Colloidal Silicon Dioxide | hold | Open workbench |
| LOT-011211 | Stearic Acid | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01212 HPLC System #213 | operational | 2026-08-17 | qualified |
| AST-01213 UV-Vis Spectrophotometer #214 | in-calibration | 2025-08-28 | requalification-due |
| AST-01214 Karl Fischer Titrator #215 | in-maintenance | 2026-05-26 | not-qualified |
| AST-01215 Dissolution Tester #216 | out-of-service | 2026-07-27 | qualified |
| AST-01216 Hardness Tester #217 | cleaning-required | 2026-06-17 | qualified |
| AST-01217 Friability Tester #218 | operational | 2025-08-10 | qualified |
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 | dev-00803 |
| Procedure Deviation | major | under-review | dev-00303 |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | dev-00803 |
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-020302
Score: 66
EBR completionComplete
Exceptions closedComplete
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.