Batch BT-020155

Bioxalin SC • SGP • L006 • 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
2025-04-15 → 2025-04-22
Actual
2026-07-20 → 2026-10-27
Exceptions
21
Release Risk
critical
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-011240Colloidal Silicon Dioxide Variant 1consumedOpen workbench
LOT-011241Stearic Acid Variant 1in-processOpen workbench
LOT-011242Titanium Dioxide Variant 1approvedOpen workbench
LOT-011243Polyethylene Glycol 400 Variant 1approvedOpen workbench
LOT-011244Polysorbate 80 Variant 1approvedOpen workbench
LOT-011245Mannitol Variant 1quarantineOpen workbench
LOT-011246Sucrose Variant 1holdOpen workbench
LOT-011247Trehalose Variant 1rejectedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01065 HVAC Unit #66operational2025-12-25qualified
AST-01066 Refrigerator #67in-calibration2026-05-13qualified
AST-01067 Freezer Ultra-Low #68in-maintenance2026-05-26qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Equipment Conflictminoropendev-00156
Equipment Conflictminoropendev-01156
Equipment Conflictminoropendev-00656
Equipment Conflictminoropendev-00156
Equipment ConflictminoropenNot linked
Equipment ConflictminoropenNot 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-020155
Score: 94
EBR completionOpen
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedComplete

Release review complete - all criteria met.

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