Batch BT-020584

Gastrivax • NWK • 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
2024-11-04 → 2024-11-07
Actual
2026-03-15 → 2025-09-20
Exceptions
3
Release Risk
medium
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-012336Methanol HPLC Grade Variant 7rejectedOpen workbench
LOT-012337Hydrochloric Acid 37% Variant 7expiredOpen workbench
LOT-012338Sodium Hydroxide Variant 7consumedOpen workbench
LOT-012339Phosphoric Acid Variant 7in-processOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01368 Lyophilizer #369in-maintenance2026-10-03requalification-due
AST-01369 Filling Machine #370out-of-service2025-09-02not-qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Out of SpecificationminorclosedNot linked
Out of Specificationminorcloseddev-00085
Out of SpecificationminorclosedNot linked
Out of Specificationminorcloseddev-00585
Out of SpecificationminorclosedNot linked
Out of SpecificationminorclosedNot 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.