Batch BT-020500

Neuraxin • DUB • L001 • 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
2025-12-20 → 2026-01-01
Actual
2026-06-17 → In progress
Exceptions
20
Release Risk
medium
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-012000Water for Injection Variant 6approvedOpen workbench
LOT-012001Purified Water Variant 6quarantineOpen workbench
LOT-012002Ethanol 95% Variant 6holdOpen workbench
LOT-012003Isopropyl Alcohol Variant 6rejectedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01200 Granulator #201in-maintenance2026-09-10qualified
AST-01201 Tablet Press #202out-of-service2025-09-13qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Material DiscrepancycriticalopenNot linked
Material Discrepancycriticalopendev-00001
Material DiscrepancycriticalopenNot linked
Material DiscrepancycriticalopenNot linked
Material DiscrepancycriticalopenNot linked
Material Discrepancycriticalopendev-01001
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.