Batch BT-020722
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
2024-11-03 → 2024-11-15
Actual
2026-11-30 → 2026-06-26
Exceptions
24
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-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 |
|---|---|---|---|
| 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 | dev-00723 |
| 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.
No release readiness record found.