Batch BT-020270
Veranide • CMO1 • L021 • in-process
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
2026-03-30 → 2026-04-07
Actual
2026-09-19 → In progress
Exceptions
5
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012700 | Active Pharmaceutical Ingredient A | approved | Open workbench |
| LOT-012701 | Active Pharmaceutical Ingredient B | approved | Open workbench |
| LOT-012702 | Active Pharmaceutical Ingredient C | approved | Open workbench |
| LOT-012703 | Microcrystalline Cellulose | quarantine | Open workbench |
| LOT-012704 | Lactose Monohydrate | hold | Open workbench |
| LOT-012705 | Hydroxypropyl Methylcellulose | rejected | Open workbench |
| LOT-012706 | Magnesium Stearate | expired | Open workbench |
| LOT-012707 | Croscarmellose Sodium | consumed | Open workbench |
| LOT-012708 | Povidone K30 | in-process | Open workbench |
| LOT-012709 | Talc | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01290 Visual Inspection System #291 | in-calibration | 2025-07-30 | qualified |
| AST-01291 Weighing Balance #292 | in-maintenance | 2026-05-11 | qualified |
| AST-01292 HPLC System #293 | out-of-service | 2024-08-18 | qualified |
| AST-01293 UV-Vis Spectrophotometer #294 | cleaning-required | 2025-09-10 | requalification-due |
| AST-01294 Karl Fischer Titrator #295 | operational | 2024-11-01 | not-qualified |
| AST-01295 Dissolution Tester #296 | operational | 2025-04-03 | qualified |
| AST-01296 Hardness Tester #297 | operational | 2025-06-03 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | dev-00771 |
| Procedure Deviation | critical | open | Not linked |
| Procedure Deviation | critical | open | dev-01271 |
| Procedure Deviation | critical | open | dev-00771 |
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-020270
Score: 100
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedOpen
Release review complete - all criteria met.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.