Batch BT-020052

Hemovance • DUB • L003 • 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
2025-10-04 → 2025-10-13
Actual
2025-10-28 → 2025-04-14
Exceptions
16
Release Risk
high
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2026-07-02T12:21:00.000Z2025-07-25T03:36:00.000Z-
002 Dispensing Startcompleted2025-04-04T07:01:00.000Z2025-04-06T19:01:00.000ZCompleted as per SOP
003 API Weighingin-progress2026-09-22T13:28:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2026-07-24T10:23:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2025-09-11T23:25:00.000Z2026-06-12T14:30:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2026-08-29T06:16:00.000Z2025-08-03T00:33:00.000Z-
008 Blending Startcompleted2025-06-21T17:35:00.000Z2025-10-18T08:52:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2025-09-20T17:11:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2026-04-26T17:21:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2025-01-29T22:12:00.000Z2025-03-03T13:48:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2025-04-19T09:33:00.000Z2026-09-29T13:20:00.000Z-
014 IPC - Tablet Friabilitycompleted2026-02-13T10:26:00.000Z2026-06-06T20:34:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2025-05-30T09:41:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2026-08-28T01:01:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2025-10-23T19:22:00.000Z2026-12-04T13:26:00.000ZCompleted as per SOP
019 Filling Setupcompleted2025-07-23T19:03:00.000Z2025-08-01T23:08:00.000Z-
020 IPC - Fill Weight Checkcompleted2026-09-24T02:33:00.000Z2026-09-18T10:18:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010156Magnesium Stearate Variant 5quarantineOpen workbench
LOT-010157Croscarmellose Sodium Variant 5holdOpen workbench
LOT-010158Povidone K30 Variant 5rejectedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01156 Metal Detector #157operational2026-10-16qualified
AST-01157 X-Ray Inspection #158in-calibration2026-06-07qualified
AST-01158 Leak Tester #159in-maintenance2025-01-03requalification-due
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check10592 to 106Pass / Pending review
API Weighing9991 to 102Pass / Pending review
IPC - Loss on Drying10294 to 110Pass / Pending review
Blending Time Verification9892 to 106Pass / Pending review
IPC - Tablet Hardness10297 to 107Pass / Pending review
IPC - Tablet Dissolution10192 to 109Pass / Pending review
Filling Setup10191 to 102Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Material Discrepancymajorunder-reviewdev-00053
Material Discrepancymajorunder-reviewdev-01053
Material Discrepancymajorunder-reviewNot linked
Material Discrepancymajorunder-reviewNot linked
Material Discrepancymajorunder-reviewNot linked
Material Discrepancymajorunder-reviewNot 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-020052
Score: 89
EBR completionComplete
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.