Batch BT-020123
Celdurin IV • SGP • L024 • 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
2026-01-19 → 2026-02-01
Actual
2024-10-31 → 2025-01-20
Exceptions
9
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010984 | Methylene Chloride Variant 2 | quarantine | Open workbench |
| LOT-010985 | Acetonitrile HPLC Grade Variant 2 | hold | Open workbench |
| LOT-010986 | Methanol HPLC Grade Variant 2 | rejected | Open workbench |
| LOT-010987 | Hydrochloric Acid 37% Variant 2 | expired | Open workbench |
| LOT-010988 | Sodium Hydroxide Variant 2 | consumed | Open workbench |
| LOT-010989 | Phosphoric Acid Variant 2 | in-process | Open workbench |
| LOT-010990 | Active Pharmaceutical Ingredient A Variant 3 | approved | Open workbench |
| LOT-010991 | Active Pharmaceutical Ingredient B Variant 3 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01184 Compressed Air System #185 | operational | 2025-12-11 | not-qualified |
| AST-01185 HVAC Unit #186 | in-calibration | 2025-10-03 | qualified |
| AST-01186 Refrigerator #187 | in-maintenance | 2026-07-11 | qualified |
| AST-01187 Freezer Ultra-Low #188 | out-of-service | 2026-01-04 | qualified |
| AST-01188 Incubator #189 | cleaning-required | 2025-04-29 | requalification-due |
| AST-01189 Autoclave Sterilizer #190 | operational | 2025-04-13 | not-qualified |
| AST-01190 Conveyor Belt #191 | operational | 2024-05-15 | qualified |
| AST-01191 Labeling Machine #192 | operational | 2025-08-01 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
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-020123
Score: 79
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.