Batch BT-020604

Bioxalin • DUB • 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
2025-04-03 → 2025-04-16
Actual
2024-07-07 → 2024-10-31
Exceptions
16
Release Risk
high
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010020Water for InjectionapprovedOpen workbench
LOT-010021Purified WaterquarantineOpen workbench
LOT-010022Ethanol 95%holdOpen workbench
LOT-010023Isopropyl AlcoholrejectedOpen workbench
LOT-010024Methylene ChlorideexpiredOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01212 HPLC System #213operational2026-08-17qualified
AST-01213 UV-Vis Spectrophotometer #214in-calibration2025-08-28requalification-due
AST-01214 Karl Fischer Titrator #215in-maintenance2026-05-26not-qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Material DiscrepancyminorclosedNot linked
Material DiscrepancyminorclosedNot linked
Material DiscrepancyminorclosedNot linked
Material Discrepancyminorcloseddev-00605
Material DiscrepancyminorclosedNot linked
Material DiscrepancyminorclosedNot 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.