Batch BT-020913

Dermazol Forte • DRH • L014 • 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
2024-10-26 → 2024-10-31
Actual
2026-05-03 → 2025-07-29
Exceptions
11
Release Risk
low
Step Timeline
StepStatusStartEndResult
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-012478Histidine Buffer Variant 2quarantineOpen workbench
LOT-012479Sodium Chloride Variant 2holdOpen workbench
LOT-012480Water for Injection Variant 2rejectedOpen workbench
LOT-012481Purified Water Variant 2expiredOpen workbench
LOT-012482Ethanol 95% Variant 2consumedOpen workbench
LOT-012483Isopropyl Alcohol Variant 2in-processOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01052 HPLC System #53in-calibration2025-10-19qualified
AST-01053 UV-Vis Spectrophotometer #54in-maintenance2025-03-25requalification-due
AST-01054 Karl Fischer Titrator #55out-of-service2025-09-28not-qualified
AST-01055 Dissolution Tester #56cleaning-required2026-02-16qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Missing SignaturemajorclosedNot linked
Missing SignaturemajorclosedNot linked
Missing Signaturemajorcloseddev-01414
Missing Signaturemajorcloseddev-00914
Missing Signaturemajorcloseddev-00414
Missing SignaturemajorclosedNot 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.