Batch BT-020443

Vakrofen • SGP • L044 • 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
2025-01-02 → 2025-01-09
Actual
2026-02-19 → 2024-11-28
Exceptions
12
Release Risk
critical
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010101Stearic Acid Variant 3approvedOpen workbench
LOT-010102Titanium Dioxide Variant 3quarantineOpen workbench
LOT-010103Polyethylene Glycol 400 Variant 3holdOpen workbench
LOT-010104Polysorbate 80 Variant 3rejectedOpen workbench
LOT-010105Mannitol Variant 3expiredOpen workbench
LOT-010106Sucrose Variant 3consumedOpen workbench
LOT-010107Trehalose Variant 3in-processOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01258 Particle Size Analyzer #259cleaning-required2026-10-10requalification-due
AST-01259 Microscope #260operational2026-08-31not-qualified
AST-01260 Laminar Flow Cabinet #261operational2025-05-26qualified
AST-01261 Isolator #262operational2025-04-05qualified
AST-01262 WFI Still #263in-calibration2025-12-30qualified
AST-01263 RO System #264in-maintenance2025-10-05requalification-due
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Equipment Conflictmajorcloseddev-00444
Equipment Conflictmajorcloseddev-01444
Equipment ConflictmajorclosedNot linked
Equipment ConflictmajorclosedNot linked
Equipment ConflictmajorclosedNot linked
Equipment Conflictmajorcloseddev-00944
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-020443
Score: 85
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedOpen

Release review in progress - minor items pending.

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