Batch BT-020050

Neuraxin • BSL • L001 • in-process

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
2024-12-24 → 2025-01-05
Actual
2024-10-04 → In progress
Exceptions
24
Release Risk
medium
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2026-05-27T20:56:00.000Z2025-09-06T16:40:00.000Z-
002 Dispensing Startcompleted2025-11-08T04:44:00.000Z2026-11-03T10:25:00.000ZCompleted as per SOP
003 API Weighingin-progress2026-11-07T06:30:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2025-12-30T14:33:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2026-09-30T12:22:00.000Z2026-02-13T15:52:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2025-01-18T20:36:00.000Z2025-05-03T11:46:00.000Z-
008 Blending Startcompleted2026-01-25T16:40:00.000Z2026-12-03T16:43:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2025-02-28T08:28:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2026-04-29T07:59:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2025-09-25T20:59:00.000Z2026-08-10T07:48:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2025-01-21T22:10:00.000Z2025-07-25T07:17:00.000Z-
014 IPC - Tablet Friabilitycompleted2026-12-21T09:48:00.000Z2026-11-10T16:15:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2025-03-23T03:23:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2025-09-03T22:22:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2026-10-08T02:47:00.000Z2026-09-15T06:43:00.000ZCompleted as per SOP
019 Filling Setupcompleted2026-10-14T04:12:00.000Z2026-07-26T18:44:00.000Z-
020 IPC - Fill Weight Checkcompleted2025-06-24T19:50:00.000Z2026-11-04T05:16:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010250Colloidal Silicon Dioxide Variant 8consumedOpen workbench
LOT-010251Stearic Acid Variant 8in-processOpen workbench
LOT-010252Titanium Dioxide Variant 8approvedOpen workbench
LOT-010253Polyethylene Glycol 400 Variant 8approvedOpen workbench
LOT-010254Polysorbate 80 Variant 8approvedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01100 Laminar Flow Cabinet #101operational2025-11-13qualified
AST-01101 Isolator #102in-calibration2024-07-18qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check10297 to 102Pass / Pending review
API Weighing9893 to 109Pass / Pending review
IPC - Loss on Drying10291 to 102Pass / Pending review
Blending Time Verification10393 to 105Pass / Pending review
IPC - Tablet Hardness10493 to 110Pass / Pending review
IPC - Tablet Dissolution10093 to 103Pass / Pending review
Filling Setup9890 to 107Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Late Stepcriticalopendev-00051
Late StepcriticalopenNot linked
Late StepcriticalopenNot linked
Late Stepcriticalopendev-00051
Late StepcriticalopenNot linked
Late StepcriticalopenNot 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-020050
Score: 81
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.