Batch BT-020854

Gastrivax • CMO1 • L005 • 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
2025-11-23 → 2025-12-06
Actual
2025-09-12 → 2026-11-07
Exceptions
22
Release Risk
medium
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-011270Colloidal Silicon Dioxide Variant 2approvedOpen workbench
LOT-011271Stearic Acid Variant 2approvedOpen workbench
LOT-011272Titanium Dioxide Variant 2quarantineOpen workbench
LOT-011273Polyethylene Glycol 400 Variant 2holdOpen workbench
LOT-011274Polysorbate 80 Variant 2rejectedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01162 Film Coater #163operational2025-10-05qualified
AST-01163 Capsule Filler #164operational2025-01-25requalification-due
AST-01164 Blender #165in-calibration2025-09-18not-qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Procedure DeviationminorclosedNot linked
Procedure DeviationminorclosedNot linked
Procedure DeviationminorclosedNot linked
Procedure DeviationminorclosedNot linked
Procedure Deviationminorcloseddev-00355
Procedure Deviationminorcloseddev-01355
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.