Batch BT-020065

Bioxalin SC • DRH • L016 • released

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
2026-06-05 → 2026-06-19
Actual
2024-02-22 → 2025-09-11
Exceptions
18
Release Risk
critical
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2026-11-08T02:26:00.000Z2025-12-05T17:57:00.000Z-
002 Dispensing Startcompleted2025-06-16T01:32:00.000Z2025-05-20T11:15:00.000ZCompleted as per SOP
003 API Weighingin-progress2025-03-03T05:40:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2025-12-08T17:03:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2025-09-15T15:42:00.000Z2025-03-13T09:23:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2025-03-26T03:52:00.000Z2025-04-22T11:26:00.000Z-
008 Blending Startcompleted2026-08-08T05:25:00.000Z2025-06-09T15:18:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2025-03-22T12:23:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2026-05-03T09:16:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2025-11-17T16:44:00.000Z2025-04-24T02:30:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2025-03-08T05:09:00.000Z2025-01-27T02:46:00.000Z-
014 IPC - Tablet Friabilitycompleted2026-08-22T19:48:00.000Z2026-05-01T21:47:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2026-10-09T09:49:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2025-10-19T15:39:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2025-05-14T19:10:00.000Z2026-02-05T00:24:00.000ZCompleted as per SOP
019 Filling Setupcompleted2026-08-24T20:34:00.000Z2025-04-21T12:55:00.000Z-
020 IPC - Fill Weight Checkcompleted2025-10-08T17:26:00.000Z2026-01-01T20:26:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010195Mannitol Variant 6expiredOpen workbench
LOT-010196Sucrose Variant 6consumedOpen workbench
LOT-010197Trehalose Variant 6in-processOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01260 Laminar Flow Cabinet #261operational2025-05-26qualified
AST-01261 Isolator #262operational2025-04-05qualified
AST-01262 WFI Still #263in-calibration2025-12-30qualified
AST-01263 RO System #264in-maintenance2025-10-05requalification-due
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check10596 to 105Pass / Pending review
API Weighing10593 to 110Pass / Pending review
IPC - Loss on Drying10497 to 102Pass / Pending review
Blending Time Verification9990 to 109Pass / Pending review
IPC - Tablet Hardness10492 to 102Pass / Pending review
IPC - Tablet Dissolution10398 to 103Pass / Pending review
Filling Setup9994 to 106Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Missing SignatureminoropenNot linked
Missing Signatureminoropendev-01066
Missing Signatureminoropendev-00566
Missing SignatureminoropenNot linked
Missing SignatureminoropenNot linked
Missing SignatureminoropenNot 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-020065
Score: 86
EBR completionOpen
Exceptions closedComplete
QC approvedComplete
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.