Batch BT-020465
Renalide • DRH • L016 • released
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
2024-05-14 → 2024-05-27
Actual
2025-07-12 → 2025-09-16
Exceptions
7
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012790 | Active Pharmaceutical Ingredient A Variant 3 | approved | Open workbench |
| LOT-012791 | Active Pharmaceutical Ingredient B Variant 3 | approved | Open workbench |
| LOT-012792 | Active Pharmaceutical Ingredient C Variant 3 | approved | Open workbench |
| LOT-012793 | Microcrystalline Cellulose Variant 3 | quarantine | Open workbench |
| LOT-012794 | Lactose Monohydrate Variant 3 | hold | Open workbench |
| LOT-012795 | Hydroxypropyl Methylcellulose Variant 3 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01260 Laminar Flow Cabinet #261 | operational | 2025-05-26 | qualified |
| AST-01261 Isolator #262 | operational | 2025-04-05 | qualified |
| AST-01262 WFI Still #263 | in-calibration | 2025-12-30 | qualified |
| AST-01263 RO System #264 | in-maintenance | 2025-10-05 | requalification-due |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | open | dev-01466 |
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | open | Not linked |
| Missing Signature | minor | open | 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-020465
Score: 84
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.