Batch BT-020024

Vakrofen ER • NWK • L025 • 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
2025-11-25 → 2025-11-29
Actual
2025-10-21 → 2024-03-03
Exceptions
0
Release Risk
low
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2025-01-16T23:57:00.000Z2026-01-03T15:40:00.000Z-
002 Dispensing Startcompleted2026-10-20T12:16:00.000Z2026-09-07T04:39:00.000ZCompleted as per SOP
003 API Weighingin-progress2026-01-28T06:37:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2025-07-31T17:51:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2025-09-10T08:30:00.000Z2025-02-28T02:32:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2026-05-31T05:22:00.000Z2025-04-12T05:55:00.000Z-
008 Blending Startcompleted2026-02-12T20:47:00.000Z2025-07-12T08:37:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2025-06-14T00:35:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2026-12-03T13:32:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2026-04-07T01:50:00.000Z2026-08-12T01:36:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2025-05-01T15:27:00.000Z2026-07-26T04:52:00.000Z-
014 IPC - Tablet Friabilitycompleted2026-02-25T04:32:00.000Z2026-12-29T20:21:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2026-12-21T14:26:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2026-12-11T21:08:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2025-11-10T14:11:00.000Z2026-05-05T05:00:00.000ZCompleted as per SOP
019 Filling Setupcompleted2026-02-21T22:24:00.000Z2025-01-31T17:02:00.000Z-
020 IPC - Fill Weight Checkcompleted2026-06-03T22:11:00.000Z2025-07-14T08:07:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010168Histidine Buffer Variant 5expiredOpen workbench
LOT-010169Sodium Chloride Variant 5consumedOpen workbench
LOT-010170Water for Injection Variant 5in-processOpen workbench
LOT-010171Purified Water Variant 5approvedOpen workbench
LOT-010172Ethanol 95% Variant 5approvedOpen workbench
LOT-010173Isopropyl Alcohol Variant 5approvedOpen workbench
LOT-010174Methylene Chloride Variant 5quarantineOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01048 Lyophilizer #49cleaning-required2025-11-03requalification-due
AST-01049 Filling Machine #50operational2025-08-25not-qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check10396 to 109Pass / Pending review
API Weighing10298 to 104Pass / Pending review
IPC - Loss on Drying9893 to 103Pass / Pending review
Blending Time Verification9893 to 102Pass / Pending review
IPC - Tablet Hardness10294 to 103Pass / Pending review
IPC - Tablet Dissolution9893 to 103Pass / Pending review
Filling Setup9896 to 107Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Out of SpecificationminorclosedNot linked
Out of SpecificationminorclosedNot linked
Out of Specificationminorcloseddev-00525
Out of SpecificationminorclosedNot linked
Out of SpecificationminorclosedNot linked
Out of SpecificationminorclosedNot 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-020024
Score: 66
EBR completionComplete
Exceptions closedComplete
QC approvedComplete
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedComplete

Release review blocked - critical items outstanding.

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