Batch BT-020668

Pulmozide • DUB • L019 • rejected

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
2024-04-27 → 2024-05-11
Actual
2026-03-10 → 2025-01-24
Exceptions
15
Release Risk
medium
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-011008Histidine Buffer Variant 3approvedOpen workbench
LOT-011009Sodium Chloride Variant 3approvedOpen workbench
LOT-011010Water for Injection Variant 3approvedOpen workbench
LOT-011011Purified Water Variant 3quarantineOpen workbench
LOT-011012Ethanol 95% Variant 3holdOpen workbench
LOT-011013Isopropyl Alcohol Variant 3rejectedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01136 Hardness Tester #137in-calibration2025-03-19qualified
AST-01137 Friability Tester #138in-maintenance2025-06-23qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Material DiscrepancyminorclosedNot linked
Material DiscrepancyminorclosedNot linked
Material DiscrepancyminorclosedNot linked
Material Discrepancyminorcloseddev-00669
Material DiscrepancyminorclosedNot linked
Material Discrepancyminorcloseddev-01169
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.