Batch BT-020348

Eptiveron HD • DUB • L049 • 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
2026-10-16 → 2026-10-29
Actual
2026-07-03 → 2024-11-27
Exceptions
4
Release Risk
low
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-012088Histidine Buffer Variant 9approvedOpen workbench
LOT-012089Sodium Chloride Variant 9approvedOpen workbench
LOT-012090Water for Injection Variant 9approvedOpen workbench
LOT-012091Purified Water Variant 9quarantineOpen workbench
LOT-012092Ethanol 95% Variant 9holdOpen workbench
LOT-012093Isopropyl Alcohol Variant 9rejectedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01088 Lyophilizer #89in-maintenance2026-09-09requalification-due
AST-01089 Filling Machine #90out-of-service2025-11-07not-qualified
AST-01090 Visual Inspection System #91cleaning-required2026-09-15qualified
AST-01091 Weighing Balance #92operational2025-10-14qualified
AST-01092 HPLC System #93operational2026-06-30qualified
AST-01093 UV-Vis Spectrophotometer #94operational2025-04-29requalification-due
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Material Discrepancyminorcloseddev-00349
Material Discrepancyminorcloseddev-01349
Material DiscrepancyminorclosedNot linked
Material Discrepancyminorcloseddev-00349
Material Discrepancyminorcloseddev-01349
Material Discrepancyminorcloseddev-00849
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.
Release Readiness: BT-020348
Score: 84
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete

Release review in progress - minor items pending.

Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.