Batch BT-020104
Gastrivax • NWK • 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
2025-02-06 → 2025-02-20
Actual
2025-03-28 → 2024-05-14
Exceptions
19
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-010416 | Methanol HPLC Grade Variant 3 | approved | Open workbench |
| LOT-010417 | Hydrochloric Acid 37% Variant 3 | quarantine | Open workbench |
| LOT-010418 | Sodium Hydroxide Variant 3 | hold | Open workbench |
| LOT-010419 | Phosphoric Acid Variant 3 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01032 Cartoning Machine #33 | in-maintenance | 2026-03-01 | qualified |
| AST-01033 Blister Packer #34 | out-of-service | 2025-04-21 | requalification-due |
| AST-01034 Shrink Wrapper #35 | cleaning-required | 2026-05-15 | not-qualified |
| AST-01035 Checkweigher #36 | operational | 2025-03-01 | qualified |
| AST-01036 Metal Detector #37 | operational | 2025-11-20 | qualified |
| AST-01037 X-Ray Inspection #38 | operational | 2026-07-11 | qualified |
| AST-01038 Leak Tester #39 | in-calibration | 2025-02-05 | requalification-due |
| AST-01039 Torque Tester #40 | in-maintenance | 2025-10-05 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | Not linked |
| Out of Specification | minor | closed | dev-00605 |
| Out of Specification | minor | closed | dev-00105 |
| Out of Specification | minor | closed | Not linked |
| Out of Specification | 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-020104
Score: 85
EBR completionOpen
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.