Batch BT-020078

Eptiveron HD • CMO1 • L029 • rejected

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
2025-02-06 → 2025-02-11
Actual
2026-06-19 → 2024-11-13
Exceptions
6
Release Risk
low
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2025-10-11T20:47:00.000Z2025-03-18T06:22:00.000Z-
002 Dispensing Startcompleted2025-05-10T21:10:00.000Z2026-11-07T21:36:00.000ZCompleted as per SOP
003 API Weighingin-progress2026-08-01T13:38:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2026-01-21T19:41:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2026-09-21T23:24:00.000Z2026-05-30T21:06:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2025-09-19T15:29:00.000Z2026-11-21T06:00:00.000Z-
008 Blending Startcompleted2025-08-18T16:01:00.000Z2025-12-28T11:44:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2026-05-21T14:53:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2026-05-26T13:57:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2025-09-05T14:56:00.000Z2025-12-24T06:37:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2026-01-10T17:50:00.000Z2026-02-25T08:48:00.000Z-
014 IPC - Tablet Friabilitycompleted2026-07-21T01:55:00.000Z2026-01-24T16:13:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2025-09-27T00:19:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2025-12-17T02:47:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2025-10-21T00:13:00.000Z2026-05-06T19:30:00.000ZCompleted as per SOP
019 Filling Setupcompleted2025-06-24T17:25:00.000Z2026-11-25T01:49:00.000Z-
020 IPC - Fill Weight Checkcompleted2025-05-27T20:10:00.000Z2025-04-19T04:03:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010390Active Pharmaceutical Ingredient A Variant 3quarantineOpen workbench
LOT-010391Active Pharmaceutical Ingredient B Variant 3holdOpen workbench
LOT-010392Active Pharmaceutical Ingredient C Variant 3rejectedOpen workbench
LOT-010393Microcrystalline Cellulose Variant 3expiredOpen workbench
LOT-010394Lactose Monohydrate Variant 3consumedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01390 Conveyor Belt #391out-of-service2025-10-24qualified
AST-01391 Labeling Machine #392cleaning-required2025-10-16qualified
AST-01392 Cartoning Machine #393operational2026-04-18qualified
AST-01393 Blister Packer #394operational2026-02-20requalification-due
AST-01394 Shrink Wrapper #395operational2026-03-22not-qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check10392 to 106Pass / Pending review
API Weighing10096 to 110Pass / Pending review
IPC - Loss on Drying9891 to 106Pass / Pending review
Blending Time Verification10096 to 110Pass / Pending review
IPC - Tablet Hardness10292 to 103Pass / Pending review
IPC - Tablet Dissolution9895 to 102Pass / Pending review
Filling Setup9994 to 108Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Procedure DeviationminorclosedNot linked
Procedure DeviationminorclosedNot linked
Procedure DeviationminorclosedNot linked
Procedure Deviationminorcloseddev-00079
Procedure DeviationminorclosedNot linked
Procedure DeviationminorclosedNot 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-020078
Score: 68
EBR completionComplete
Exceptions closedComplete
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.