Batch BT-020310

Nexipar • CMO1 • L011 • in-process

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
2024-08-19 → 2024-08-29
Actual
2025-09-06 → In progress
Exceptions
9
Release Risk
high
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-012170Colloidal Silicon Dioxide Variant 2approvedOpen workbench
LOT-012171Stearic Acid Variant 2approvedOpen workbench
LOT-012172Titanium Dioxide Variant 2quarantineOpen workbench
LOT-012173Polyethylene Glycol 400 Variant 2holdOpen workbench
LOT-012174Polysorbate 80 Variant 2rejectedOpen workbench
LOT-012175Mannitol Variant 2expiredOpen workbench
LOT-012176Sucrose Variant 2consumedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01130 Visual Inspection System #131in-maintenance2025-09-14qualified
AST-01131 Weighing Balance #132out-of-service2026-02-22qualified
AST-01132 HPLC System #133cleaning-required2026-03-27qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Procedure Deviationcriticalopendev-00311
Procedure Deviationcriticalopendev-01311
Procedure DeviationcriticalopenNot linked
Procedure Deviationcriticalopendev-00311
Procedure DeviationcriticalopenNot linked
Procedure Deviationcriticalopendev-00811
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-020310
Score: 61
EBR completionOpen
Exceptions closedOpen
QC approvedOpen
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.