Batch BT-020165
Renalide • PPL • 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
2026-09-07 → 2026-09-12
Actual
2024-01-24 → 2025-10-22
Exceptions
9
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011320 | Active Pharmaceutical Ingredient A Variant 4 | expired | Open workbench |
| LOT-011321 | Active Pharmaceutical Ingredient B Variant 4 | consumed | Open workbench |
| LOT-011322 | Active Pharmaceutical Ingredient C Variant 4 | in-process | Open workbench |
| LOT-011323 | Microcrystalline Cellulose Variant 4 | approved | Open workbench |
| LOT-011324 | Lactose Monohydrate Variant 4 | approved | Open workbench |
| LOT-011325 | Hydroxypropyl Methylcellulose Variant 4 | approved | Open workbench |
| LOT-011326 | Magnesium Stearate Variant 4 | quarantine | Open workbench |
| LOT-011327 | Croscarmellose Sodium Variant 4 | hold | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01190 Conveyor Belt #191 | operational | 2024-05-15 | qualified |
| AST-01191 Labeling Machine #192 | operational | 2025-08-01 | qualified |
| AST-01192 Cartoning Machine #193 | in-calibration | 2025-07-17 | qualified |
| AST-01193 Blister Packer #194 | in-maintenance | 2026-05-01 | requalification-due |
| AST-01194 Shrink Wrapper #195 | out-of-service | 2026-02-07 | not-qualified |
| AST-01195 Checkweigher #196 | cleaning-required | 2026-01-16 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | minor | open | dev-00166 |
| Environmental Excursion | minor | open | Not linked |
| Environmental Excursion | minor | open | Not linked |
| Environmental Excursion | minor | open | Not linked |
| Environmental Excursion | minor | open | dev-01166 |
| Environmental Excursion | minor | open | dev-00666 |
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-020165
Score: 79
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantOpen
Training confirmedComplete
Release review in progress - minor items pending.
Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.