Batch BT-020257
Eptiveron • DRH • L008 • on-hold
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
2024-01-13 → 2024-01-21
Actual
2026-08-29 → In progress
Exceptions
20
Release Risk
critical
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011285 | Acetonitrile HPLC Grade Variant 2 | consumed | Open workbench |
| LOT-011286 | Methanol HPLC Grade Variant 2 | in-process | Open workbench |
| LOT-011287 | Hydrochloric Acid 37% Variant 2 | approved | Open workbench |
| LOT-011288 | Sodium Hydroxide Variant 2 | approved | Open workbench |
| LOT-011289 | Phosphoric Acid Variant 2 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01371 Weighing Balance #372 | operational | 2025-10-07 | qualified |
| AST-01372 HPLC System #373 | operational | 2026-10-31 | qualified |
| AST-01373 UV-Vis Spectrophotometer #374 | operational | 2025-01-15 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | minor | under-review | dev-00258 |
| Missing Signature | minor | under-review | dev-01258 |
| Missing Signature | minor | under-review | Not linked |
| Missing Signature | minor | under-review | dev-00258 |
| Missing Signature | minor | under-review | dev-01258 |
| Missing Signature | minor | 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-020257
Score: 98
EBR completionOpen
Exceptions closedComplete
QC approvedOpen
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.