Batch BT-020060

Veranide • DUB • L011 • 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
2024-07-29 → 2024-08-04
Actual
2026-01-19 → In progress
Exceptions
18
Release Risk
low
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2026-07-01T09:12:00.000Z2026-01-24T22:10:00.000Z-
002 Dispensing Startcompleted2026-04-13T16:53:00.000Z2025-08-15T17:07:00.000ZCompleted as per SOP
003 API Weighingin-progress2026-08-31T18:35:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2026-08-09T10:00:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2026-07-02T01:33:00.000Z2026-05-21T13:27:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2026-06-04T10:12:00.000Z2025-02-11T05:25:00.000Z-
008 Blending Startcompleted2026-05-06T19:51:00.000Z2025-10-16T18:31:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2025-09-24T19:45:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2025-10-03T13:57:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2026-11-13T18:39:00.000Z2026-08-19T08:36:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2026-11-22T09:09:00.000Z2026-02-12T00:13:00.000Z-
014 IPC - Tablet Friabilitycompleted2026-10-01T15:29:00.000Z2025-10-19T00:52:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2026-03-05T10:38:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2026-09-25T00:09:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2026-03-09T01:10:00.000Z2025-11-01T08:00:00.000ZCompleted as per SOP
019 Filling Setupcompleted2026-08-22T05:12:00.000Z2025-06-01T19:06:00.000Z-
020 IPC - Fill Weight Checkcompleted2025-08-24T15:42:00.000Z2026-01-07T22:17:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010300Active Pharmaceutical Ingredient AquarantineOpen workbench
LOT-010301Active Pharmaceutical Ingredient BholdOpen workbench
LOT-010302Active Pharmaceutical Ingredient CrejectedOpen workbench
LOT-010303Microcrystalline CelluloseexpiredOpen workbench
LOT-010304Lactose MonohydrateconsumedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01120 Granulator #121operational2024-11-05qualified
AST-01121 Tablet Press #122operational2026-06-17qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check10392 to 106Pass / Pending review
API Weighing10192 to 108Pass / Pending review
IPC - Loss on Drying10493 to 105Pass / Pending review
Blending Time Verification10594 to 106Pass / Pending review
IPC - Tablet Hardness10492 to 109Pass / Pending review
IPC - Tablet Dissolution10192 to 102Pass / Pending review
Filling Setup10594 to 104Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Material DiscrepancycriticalopenNot linked
Material DiscrepancycriticalopenNot linked
Material Discrepancycriticalopendev-00561
Material Discrepancycriticalopendev-00061
Material DiscrepancycriticalopenNot linked
Material DiscrepancycriticalopenNot 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-020060
Score: 80
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.