Batch BT-020095

Bioxalin SC • CMO2 • L046 • 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
2024-11-08 → 2024-11-15
Actual
2025-08-23 → 2024-08-21
Exceptions
7
Release Risk
critical
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2025-03-28T00:13:00.000Z2026-06-19T23:37:00.000Z-
002 Dispensing Startcompleted2025-03-20T08:06:00.000Z2026-02-06T11:34:00.000ZCompleted as per SOP
003 API Weighingin-progress2026-08-24T21:24:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2025-08-20T13:26:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2026-04-23T11:10:00.000Z2026-09-03T20:32:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2026-10-08T18:12:00.000Z2025-05-28T12:57:00.000Z-
008 Blending Startcompleted2026-04-27T01:46:00.000Z2026-05-28T13:34:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2025-09-22T22:49:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2026-10-07T14:42:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2025-03-31T20:31:00.000Z2025-01-30T19:46:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2025-09-17T14:47:00.000Z2026-10-10T14:42:00.000Z-
014 IPC - Tablet Friabilitycompleted2025-01-11T17:53:00.000Z2026-07-03T04:06:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2026-10-09T04:50:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2025-07-23T15:47:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2026-03-05T07:42:00.000Z2025-10-06T06:10:00.000ZCompleted as per SOP
019 Filling Setupcompleted2026-04-16T17:23:00.000Z2025-02-24T16:03:00.000Z-
020 IPC - Fill Weight Checkcompleted2026-07-01T06:22:00.000Z2026-02-04T19:40:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010760Colloidal Silicon Dioxide Variant 5holdOpen workbench
LOT-010761Stearic Acid Variant 5rejectedOpen workbench
LOT-010762Titanium Dioxide Variant 5expiredOpen workbench
LOT-010763Polyethylene Glycol 400 Variant 5consumedOpen workbench
LOT-010764Polysorbate 80 Variant 5in-processOpen workbench
LOT-010765Mannitol Variant 5approvedOpen workbench
LOT-010766Sucrose Variant 5approvedOpen workbench
LOT-010767Trehalose Variant 5approvedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01075 Checkweigher #76out-of-service2026-09-09qualified
AST-01076 Metal Detector #77cleaning-required2024-05-27qualified
AST-01077 X-Ray Inspection #78operational2026-03-10qualified
AST-01078 Leak Tester #79operational2025-08-12requalification-due
AST-01079 Torque Tester #80operational2026-02-22not-qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check9896 to 106Pass / Pending review
API Weighing10595 to 107Pass / Pending review
IPC - Loss on Drying10196 to 105Pass / Pending review
Blending Time Verification10190 to 108Pass / Pending review
IPC - Tablet Hardness10092 to 107Pass / Pending review
IPC - Tablet Dissolution9996 to 109Pass / Pending review
Filling Setup10197 to 102Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
System ErrorminoropenNot linked
System ErrorminoropenNot linked
System ErrorminoropenNot linked
System ErrorminoropenNot linked
System ErrorminoropenNot linked
System ErrorminoropenNot 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-020095
Score: 78
EBR completionComplete
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.