Batch BT-020404
Gastrivax • DUB • L005 • 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
2024-10-12 → 2024-10-17
Actual
2025-10-16 → 2026-01-28
Exceptions
12
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010232 | Ethanol 95% Variant 7 | consumed | Open workbench |
| LOT-010233 | Isopropyl Alcohol Variant 7 | in-process | Open workbench |
| LOT-010234 | Methylene Chloride Variant 7 | approved | Open workbench |
| LOT-010235 | Acetonitrile HPLC Grade Variant 7 | approved | Open workbench |
| LOT-010236 | Methanol HPLC Grade Variant 7 | approved | Open workbench |
| LOT-010237 | Hydrochloric Acid 37% Variant 7 | quarantine | Open workbench |
| LOT-010238 | Sodium Hydroxide Variant 7 | hold | Open workbench |
| LOT-010239 | Phosphoric Acid Variant 7 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01016 Hardness Tester #17 | operational | 2024-07-12 | qualified |
| AST-01017 Friability Tester #18 | in-calibration | 2025-04-30 | qualified |
| AST-01018 Particle Size Analyzer #19 | in-maintenance | 2025-09-18 | requalification-due |
| AST-01019 Microscope #20 | out-of-service | 2026-03-22 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Material Discrepancy | minor | closed | dev-00405 |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | Not linked |
| Material Discrepancy | minor | closed | dev-01405 |
| Material Discrepancy | minor | closed | 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-020404
Score: 88
EBR completionComplete
Exceptions closedOpen
QC approvedComplete
Deviations dispositionedOpen
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.