Batch BT-020122
Celdurin • BSL • 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
2024-01-25 → 2024-02-05
Actual
2024-02-16 → 2025-04-02
Exceptions
15
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011220 | Water for Injection | rejected | Open workbench |
| LOT-011221 | Purified Water | expired | Open workbench |
| LOT-011222 | Ethanol 95% | consumed | Open workbench |
| LOT-011223 | Isopropyl Alcohol | in-process | Open workbench |
| LOT-011224 | Methylene Chloride | approved | Open workbench |
| LOT-011225 | Acetonitrile HPLC Grade | approved | Open workbench |
| LOT-011226 | Methanol HPLC Grade | approved | Open workbench |
| LOT-011227 | Hydrochloric Acid 37% | quarantine | Open workbench |
| LOT-011228 | Sodium Hydroxide | hold | Open workbench |
| LOT-011229 | Phosphoric Acid | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01366 Bioreactor #367 | operational | 2024-08-10 | qualified |
| AST-01367 Centrifuge #368 | in-calibration | 2025-04-10 | qualified |
| AST-01368 Lyophilizer #369 | in-maintenance | 2026-10-03 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Late Step | major | under-review | Not linked |
| Late Step | major | under-review | dev-01123 |
| Late Step | major | under-review | Not linked |
| Late Step | major | under-review | Not linked |
| Late Step | major | under-review | Not linked |
| Late Step | 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-020122
Score: 99
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.