Batch BT-020234

Vakrofen ER • BSL • L035 • 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
2024-09-18 → 2024-09-26
Actual
2024-05-14 → 2026-03-16
Exceptions
3
Release Risk
low
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010936Magnesium Stearate Variant 1approvedOpen workbench
LOT-010937Croscarmellose Sodium Variant 1approvedOpen workbench
LOT-010938Povidone K30 Variant 1approvedOpen workbench
LOT-010939Talc Variant 1quarantineOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01302 WFI Still #303operational2025-11-25qualified
AST-01303 RO System #304operational2026-05-07requalification-due
AST-01304 Compressed Air System #305in-calibration2026-05-29not-qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Late Stepminorcloseddev-00235
Late StepminorclosedNot linked
Late StepminorclosedNot linked
Late Stepminorcloseddev-00235
Late StepminorclosedNot linked
Late StepminorclosedNot 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.
Release Readiness: BT-020234
Score: 78
EBR completionOpen
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedOpen
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.