Batch BT-020349
Corazyme • PPL • L050 • planned
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
2024-10-28 → 2024-11-11
Actual
Pending → In progress
Exceptions
21
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-011396 | Sucrose Variant 6 | approved | Open workbench |
| LOT-011397 | Trehalose Variant 6 | approved | Open workbench |
| LOT-011398 | Histidine Buffer Variant 6 | quarantine | Open workbench |
| LOT-011399 | Sodium Chloride Variant 6 | hold | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01043 Capsule Filler #44 | operational | 2026-01-03 | requalification-due |
| AST-01044 Blender #45 | operational | 2025-10-02 | not-qualified |
| AST-01045 Autoclave #46 | in-calibration | 2025-10-23 | qualified |
| AST-01046 Bioreactor #47 | in-maintenance | 2025-07-26 | qualified |
| AST-01047 Centrifuge #48 | out-of-service | 2026-01-16 | qualified |
| AST-01048 Lyophilizer #49 | cleaning-required | 2025-11-03 | requalification-due |
| AST-01049 Filling Machine #50 | operational | 2025-08-25 | not-qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | minor | closed | Not linked |
| Environmental Excursion | minor | closed | dev-01350 |
| Environmental Excursion | minor | closed | Not linked |
| Environmental Excursion | minor | closed | Not linked |
| Environmental Excursion | minor | closed | dev-01350 |
| Environmental Excursion | minor | closed | 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-020349
Score: 78
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
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.