Batch BT-020073

Dermazol Forte • DRH • L024 • 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
2026-05-19 → 2026-05-26
Actual
2026-11-14 → 2025-03-15
Exceptions
19
Release Risk
low
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2025-07-14T06:03:00.000Z2025-03-30T22:55:00.000Z-
002 Dispensing Startcompleted2025-09-28T02:28:00.000Z2026-02-25T21:50:00.000ZCompleted as per SOP
003 API Weighingin-progress2025-09-21T04:54:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2026-11-23T05:44:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2026-11-11T13:26:00.000Z2025-10-03T06:41:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2025-05-02T07:33:00.000Z2025-02-01T08:57:00.000Z-
008 Blending Startcompleted2025-10-30T05:00:00.000Z2026-09-28T01:36:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2025-11-14T03:55:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2026-12-25T23:30:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2026-01-05T11:44:00.000Z2025-03-18T17:34:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2026-10-27T12:15:00.000Z2025-11-27T06:26:00.000Z-
014 IPC - Tablet Friabilitycompleted2026-12-22T09:11:00.000Z2026-01-31T16:22:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2025-07-16T20:19:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2026-10-22T18:15:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2025-10-31T09:38:00.000Z2025-07-15T01:53:00.000ZCompleted as per SOP
019 Filling Setupcompleted2026-01-18T11:59:00.000Z2025-03-25T13:33:00.000Z-
020 IPC - Fill Weight Checkcompleted2026-03-06T22:57:00.000Z2025-08-29T11:32:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010219Talc Variant 7quarantineOpen workbench
LOT-010220Colloidal Silicon Dioxide Variant 7holdOpen workbench
LOT-010221Stearic Acid Variant 7rejectedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01146 Refrigerator #147cleaning-required2025-06-15qualified
AST-01147 Freezer Ultra-Low #148operational2025-02-07qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check10395 to 109Pass / Pending review
API Weighing10195 to 110Pass / Pending review
IPC - Loss on Drying10394 to 102Pass / Pending review
Blending Time Verification10496 to 102Pass / Pending review
IPC - Tablet Hardness10495 to 106Pass / Pending review
IPC - Tablet Dissolution10395 to 105Pass / Pending review
Filling Setup10592 to 102Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Missing SignaturemajorclosedNot linked
Missing SignaturemajorclosedNot linked
Missing SignaturemajorclosedNot linked
Missing SignaturemajorclosedNot linked
Missing SignaturemajorclosedNot linked
Missing Signaturemajorcloseddev-00574
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-020073
Score: 63
EBR completionOpen
Exceptions closedOpen
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete

Release review blocked - critical items outstanding.

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