Batch BT-020964

Bioxalin • DUB • L015 • 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
2026-02-17 → 2026-02-21
Actual
2025-04-21 → 2026-04-20
Exceptions
1
Release Risk
high
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-012892Titanium Dioxide Variant 6quarantineOpen workbench
LOT-012893Polyethylene Glycol 400 Variant 6holdOpen workbench
LOT-012894Polysorbate 80 Variant 6rejectedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01020 Laminar Flow Cabinet #21cleaning-required2025-06-20qualified
AST-01021 Isolator #22operational2025-12-23qualified
AST-01022 WFI Still #23operational2025-10-20qualified
AST-01023 RO System #24operational2024-12-20requalification-due
AST-01024 Compressed Air System #25in-calibration2025-01-26not-qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Material DiscrepancyminorclosedNot linked
Material DiscrepancyminorclosedNot linked
Material DiscrepancyminorclosedNot linked
Material DiscrepancyminorclosedNot linked
Material Discrepancyminorcloseddev-00465
Material Discrepancyminorcloseddev-01465
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.