Batch BT-020403
Dermazol Forte • SGP • 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
2026-07-08 → 2026-07-15
Actual
2025-05-14 → 2025-05-09
Exceptions
11
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012418 | Histidine Buffer | expired | Open workbench |
| LOT-012419 | Sodium Chloride | consumed | Open workbench |
| LOT-012420 | Water for Injection | in-process | Open workbench |
| LOT-012421 | Purified Water | approved | Open workbench |
| LOT-012422 | Ethanol 95% | approved | Open workbench |
| LOT-012423 | Isopropyl Alcohol | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| 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 |
| AST-01020 Laminar Flow Cabinet #21 | cleaning-required | 2025-06-20 | qualified |
| AST-01021 Isolator #22 | operational | 2025-12-23 | qualified |
| AST-01022 WFI Still #23 | operational | 2025-10-20 | qualified |
| AST-01023 RO System #24 | operational | 2024-12-20 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
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-020403
Score: 91
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.