Batch BT-020144
Vakrofen ER • NWK • L045 • 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
2024-07-08 → 2024-07-16
Actual
2025-09-10 → 2024-01-05
Exceptions
12
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011296 | Magnesium Stearate Variant 3 | approved | Open workbench |
| LOT-011297 | Croscarmellose Sodium Variant 3 | approved | Open workbench |
| LOT-011298 | Povidone K30 Variant 3 | approved | Open workbench |
| LOT-011299 | Talc Variant 3 | quarantine | Open workbench |
| LOT-011300 | Colloidal Silicon Dioxide Variant 3 | hold | Open workbench |
| LOT-011301 | Stearic Acid Variant 3 | rejected | Open workbench |
| LOT-011302 | Titanium Dioxide Variant 3 | expired | Open workbench |
| LOT-011303 | Polyethylene Glycol 400 Variant 3 | consumed | Open workbench |
| LOT-011304 | Polysorbate 80 Variant 3 | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01320 Granulator #321 | out-of-service | 2026-03-30 | qualified |
| AST-01321 Tablet Press #322 | cleaning-required | 2025-04-30 | qualified |
| AST-01322 Film Coater #323 | operational | 2025-04-11 | qualified |
| AST-01323 Capsule Filler #324 | operational | 2025-10-01 | requalification-due |
| AST-01324 Blender #325 | operational | 2026-07-10 | 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 | Not linked |
| Out of Specification | minor | closed | Not linked |
| 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-020144
Score: 96
EBR completionComplete
Exceptions closedOpen
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.