Batch BT-020979

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
2025-05-23 → 2025-05-27
Actual
Pending → In progress
Exceptions
13
Release Risk
low
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-011895Hydroxypropyl Methylcellulose Variant 3rejectedOpen workbench
LOT-011896Magnesium Stearate Variant 3expiredOpen workbench
LOT-011897Croscarmellose Sodium Variant 3consumedOpen workbench
LOT-011898Povidone K30 Variant 3in-processOpen workbench
LOT-011899Talc Variant 3approvedOpen 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 ConflictminorclosedNot linked
Equipment ConflictminorclosedNot linked
Equipment Conflictminorcloseddev-01480
Equipment ConflictminorclosedNot linked
Equipment ConflictminorclosedNot linked
Equipment ConflictminorclosedNot 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.
No release readiness record found.