Batch BT-020565
Aziroline • PPL • L016 • released
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
2024-07-04 → 2024-07-10
Actual
2026-04-26 → 2024-03-26
Exceptions
18
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010955 | Acetonitrile HPLC Grade Variant 1 | approved | Open workbench |
| LOT-010956 | Methanol HPLC Grade Variant 1 | approved | Open workbench |
| LOT-010957 | Hydrochloric Acid 37% Variant 1 | quarantine | Open workbench |
| LOT-010958 | Sodium Hydroxide Variant 1 | hold | Open workbench |
| LOT-010959 | Phosphoric Acid Variant 1 | rejected | Open workbench |
| LOT-010960 | Active Pharmaceutical Ingredient A Variant 2 | expired | Open workbench |
| LOT-010961 | Active Pharmaceutical Ingredient B Variant 2 | consumed | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01260 Laminar Flow Cabinet #261 | operational | 2025-05-26 | qualified |
| AST-01261 Isolator #262 | operational | 2025-04-05 | qualified |
| AST-01262 WFI Still #263 | in-calibration | 2025-12-30 | qualified |
| AST-01263 RO System #264 | in-maintenance | 2025-10-05 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | minor | open | dev-00566 |
| Environmental Excursion | minor | open | Not linked |
| Environmental Excursion | minor | open | dev-01066 |
| Environmental Excursion | minor | open | Not linked |
| Environmental Excursion | minor | open | dev-00066 |
| Environmental Excursion | minor | open | dev-01066 |
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.