Batch BT-020379

Corazyme • SGP • L030 • 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
2026-08-19 → 2026-08-22
Actual
Pending → In progress
Exceptions
23
Release Risk
low
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010032Active Pharmaceutical Ingredient C Variant 1rejectedOpen workbench
LOT-010033Microcrystalline Cellulose Variant 1expiredOpen workbench
LOT-010034Lactose Monohydrate Variant 1consumedOpen workbench
LOT-010035Hydroxypropyl Methylcellulose Variant 1in-processOpen workbench
LOT-010036Magnesium Stearate Variant 1approvedOpen workbench
LOT-010037Croscarmellose Sodium Variant 1approvedOpen workbench
LOT-010038Povidone K30 Variant 1approvedOpen workbench
LOT-010039Talc Variant 1quarantineOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01358 Leak Tester #359operational2025-04-08requalification-due
AST-01359 Torque Tester #360operational2025-07-28not-qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Equipment Conflictminorcloseddev-00380
Equipment ConflictminorclosedNot linked
Equipment ConflictminorclosedNot linked
Equipment Conflictminorcloseddev-00380
Equipment ConflictminorclosedNot linked
Equipment Conflictminorcloseddev-00880
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-020379
Score: 60
EBR completionOpen
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete

Release review blocked - critical items outstanding.

Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.