Batch BT-020018

Eptiveron HD • BSL • L019 • 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
2024-05-22 → 2024-05-28
Actual
2025-06-09 → 2024-09-23
Exceptions
22
Release Risk
low
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2025-07-25T04:24:00.000Z2026-10-08T00:58:00.000Z-
002 Dispensing Startcompleted2026-05-31T10:01:00.000Z2026-03-23T20:37:00.000ZCompleted as per SOP
003 API Weighingin-progress2026-05-07T23:46:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2025-07-15T09:59:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2025-09-03T11:02:00.000Z2026-11-29T04:06:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2025-01-13T21:05:00.000Z2026-01-07T02:46:00.000Z-
008 Blending Startcompleted2025-04-23T13:42:00.000Z2025-09-11T15:14:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2025-03-08T08:47:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2026-10-08T02:54:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2025-04-12T04:44:00.000Z2026-05-02T02:56:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2026-11-06T23:15:00.000Z2025-01-18T12:45:00.000Z-
014 IPC - Tablet Friabilitycompleted2026-09-04T23:57:00.000Z2025-09-26T10:46:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2026-09-30T02:22:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2026-08-31T22:28:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2026-05-26T21:34:00.000Z2026-04-02T06:17:00.000ZCompleted as per SOP
019 Filling Setupcompleted2026-09-19T20:56:00.000Z2025-08-16T17:35:00.000Z-
020 IPC - Fill Weight Checkcompleted2025-03-08T13:14:00.000Z2025-06-11T18:45:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010108Histidine Buffer Variant 3approvedOpen workbench
LOT-010109Sodium Chloride Variant 3approvedOpen workbench
LOT-010110Water for Injection Variant 3approvedOpen workbench
LOT-010111Purified Water Variant 3quarantineOpen workbench
LOT-010112Ethanol 95% Variant 3holdOpen workbench
LOT-010113Isopropyl Alcohol Variant 3rejectedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01108 Incubator #109in-calibration2025-09-02requalification-due
AST-01109 Autoclave Sterilizer #110in-maintenance2026-07-20not-qualified
AST-01110 Conveyor Belt #111out-of-service2025-10-12qualified
AST-01111 Labeling Machine #112cleaning-required2025-12-10qualified
AST-01112 Cartoning Machine #113operational2026-01-29qualified
AST-01113 Blister Packer #114operational2026-01-03requalification-due
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check10595 to 109Pass / Pending review
API Weighing10195 to 109Pass / Pending review
IPC - Loss on Drying10094 to 103Pass / Pending review
Blending Time Verification9890 to 105Pass / Pending review
IPC - Tablet Hardness10398 to 106Pass / Pending review
IPC - Tablet Dissolution10597 to 108Pass / Pending review
Filling Setup10390 to 107Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Late Stepminorcloseddev-00019
Late StepminorclosedNot linked
Late Stepminorcloseddev-00519
Late StepminorclosedNot linked
Late Stepminorcloseddev-01019
Late Stepminorcloseddev-00519
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-020018
Score: 86
EBR completionComplete
Exceptions closedComplete
QC approvedOpen
Deviations dispositionedComplete
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.