Batch BT-020059

Vaccelox • SGP • L010 • planned

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
2025-11-28 → 2025-12-11
Actual
Pending → In progress
Exceptions
7
Release Risk
critical
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2025-09-18T13:27:00.000Z2026-10-10T11:40:00.000Z-
002 Dispensing Startcompleted2025-06-13T22:45:00.000Z2026-05-20T03:13:00.000ZCompleted as per SOP
003 API Weighingin-progress2026-03-24T04:59:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2025-08-25T01:55:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2026-06-23T19:48:00.000Z2026-03-14T09:15:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2026-03-30T13:40:00.000Z2025-09-19T22:46:00.000Z-
008 Blending Startcompleted2026-07-20T16:37:00.000Z2026-04-12T09:00:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2026-04-25T17:55:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2025-08-05T11:36:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2025-06-24T22:18:00.000Z2025-06-30T05:57:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2026-02-16T14:22:00.000Z2025-12-12T14:34:00.000Z-
014 IPC - Tablet Friabilitycompleted2026-04-18T22:46:00.000Z2025-06-22T08:48:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2026-01-01T10:56:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2026-04-10T12:13:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2025-12-31T20:05:00.000Z2026-05-19T00:31:00.000ZCompleted as per SOP
019 Filling Setupcompleted2026-07-29T06:01:00.000Z2026-09-25T14:45:00.000Z-
020 IPC - Fill Weight Checkcompleted2025-11-02T02:16:00.000Z2026-11-20T20:08:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010295Acetonitrile HPLC Grade Variant 9consumedOpen workbench
LOT-010296Methanol HPLC Grade Variant 9in-processOpen workbench
LOT-010297Hydrochloric Acid 37% Variant 9approvedOpen workbench
LOT-010298Sodium Hydroxide Variant 9approvedOpen workbench
LOT-010299Phosphoric Acid Variant 9approvedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01354 Shrink Wrapper #355in-maintenance2024-08-19not-qualified
AST-01355 Checkweigher #356out-of-service2025-02-02qualified
AST-01356 Metal Detector #357cleaning-required2024-07-22qualified
AST-01357 X-Ray Inspection #358operational2026-03-02qualified
AST-01358 Leak Tester #359operational2025-04-08requalification-due
AST-01359 Torque Tester #360operational2025-07-28not-qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check9892 to 103Pass / Pending review
API Weighing10096 to 110Pass / Pending review
IPC - Loss on Drying10590 to 108Pass / Pending review
Blending Time Verification10298 to 106Pass / Pending review
IPC - Tablet Hardness9996 to 106Pass / Pending review
IPC - Tablet Dissolution10295 to 106Pass / Pending review
Filling Setup10096 to 107Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Equipment Conflictminorcloseddev-00060
Equipment Conflictminorcloseddev-01060
Equipment Conflictminorcloseddev-00560
Equipment ConflictminorclosedNot linked
Equipment ConflictminorclosedNot linked
Equipment Conflictminorcloseddev-00560
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-020059
Score: 62
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedOpen
Calibration compliantComplete
Training confirmedOpen

Release review blocked - critical items outstanding.

Disposition recommendation is simulated and requires QA Reviewer persona sign-off before final approval.