Batch BT-020353
Vakrofen • DRH • L004 • 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
2024-01-12 → 2024-01-17
Actual
2024-01-27 → 2026-11-09
Exceptions
3
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012118 | Histidine Buffer | quarantine | Open workbench |
| LOT-012119 | Sodium Chloride | hold | Open workbench |
| LOT-012120 | Water for Injection | rejected | Open workbench |
| LOT-012121 | Purified Water | expired | Open workbench |
| LOT-012122 | Ethanol 95% | consumed | Open workbench |
| LOT-012123 | Isopropyl Alcohol | in-process | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01118 Leak Tester #119 | cleaning-required | 2025-03-26 | requalification-due |
| AST-01119 Torque Tester #120 | operational | 2025-07-30 | not-qualified |
| AST-01120 Granulator #121 | operational | 2024-11-05 | qualified |
| AST-01121 Tablet Press #122 | operational | 2026-06-17 | qualified |
| AST-01122 Film Coater #123 | in-calibration | 2025-03-07 | qualified |
| AST-01123 Capsule Filler #124 | in-maintenance | 2025-01-24 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | major | closed | Not linked |
| Missing Signature | major | closed | Not linked |
| Missing Signature | major | closed | Not linked |
| Missing Signature | major | closed | Not linked |
| Missing Signature | major | closed | Not linked |
| Missing Signature | major | 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-020353
Score: 66
EBR completionComplete
Exceptions closedOpen
QC approvedComplete
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedOpen
Release review blocked - critical items outstanding.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.