Batch BT-020462
Dermazol • CMO1 • L013 • 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
2026-01-30 → 2026-02-07
Actual
2026-01-10 → 2024-06-12
Exceptions
8
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011848 | Histidine Buffer Variant 1 | quarantine | Open workbench |
| LOT-011849 | Sodium Chloride Variant 1 | hold | Open workbench |
| LOT-011850 | Water for Injection Variant 1 | rejected | Open workbench |
| LOT-011851 | Purified Water Variant 1 | expired | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01372 HPLC System #373 | operational | 2026-10-31 | qualified |
| AST-01373 UV-Vis Spectrophotometer #374 | operational | 2025-01-15 | requalification-due |
| AST-01374 Karl Fischer Titrator #375 | in-calibration | 2026-05-11 | not-qualified |
| AST-01375 Dissolution Tester #376 | in-maintenance | 2024-08-23 | qualified |
| AST-01376 Hardness Tester #377 | out-of-service | 2026-09-13 | qualified |
| AST-01377 Friability Tester #378 | cleaning-required | 2025-09-10 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | dev-00963 |
| Procedure Deviation | major | under-review | dev-00463 |
| Procedure Deviation | major | under-review | Not linked |
| Procedure Deviation | major | under-review | 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-020462
Score: 100
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedOpen
Calibration compliantOpen
Training confirmedComplete
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.