Batch BT-020723

Celdurin IV • SGP • L024 • completed

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
2024-07-12 → 2024-07-15
Actual
2024-12-05 → 2025-05-03
Exceptions
8
Release Risk
medium
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-012784Methylene Chloride Variant 2quarantineOpen workbench
LOT-012785Acetonitrile HPLC Grade Variant 2holdOpen workbench
LOT-012786Methanol HPLC Grade Variant 2rejectedOpen workbench
LOT-012787Hydrochloric Acid 37% Variant 2expiredOpen workbench
LOT-012788Sodium Hydroxide Variant 2consumedOpen workbench
LOT-012789Phosphoric Acid Variant 2in-processOpen workbench
LOT-012790Active Pharmaceutical Ingredient A Variant 3approvedOpen workbench
LOT-012791Active Pharmaceutical Ingredient B Variant 3approvedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01169 Filling Machine #170operational2026-04-30not-qualified
AST-01170 Visual Inspection System #171operational2025-02-18qualified
AST-01171 Weighing Balance #172in-calibration2025-05-11qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Equipment ConflictmajorclosedNot linked
Equipment ConflictmajorclosedNot linked
Equipment Conflictmajorcloseddev-01224
Equipment Conflictmajorcloseddev-00724
Equipment Conflictmajorcloseddev-00224
Equipment ConflictmajorclosedNot 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.