Batch BT-020075

Renalide • SGP • L026 • 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
2025-05-24 → 2025-06-01
Actual
2024-03-18 → 2024-08-29
Exceptions
10
Release Risk
medium
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2026-03-29T07:15:00.000Z2026-12-29T10:09:00.000Z-
002 Dispensing Startcompleted2025-04-24T22:17:00.000Z2026-09-26T23:26:00.000ZCompleted as per SOP
003 API Weighingin-progress2026-02-18T12:27:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2025-05-29T03:19:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2026-09-02T14:24:00.000Z2026-09-20T05:33:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2026-11-20T20:40:00.000Z2026-05-14T15:24:00.000Z-
008 Blending Startcompleted2025-05-06T05:44:00.000Z2025-10-19T21:27:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2025-05-25T11:56:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2025-10-19T05:54:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2026-02-20T20:32:00.000Z2025-01-23T05:06:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2026-01-29T08:34:00.000Z2025-05-14T04:23:00.000Z-
014 IPC - Tablet Friabilitycompleted2025-08-24T07:27:00.000Z2026-09-21T19:35:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2025-11-12T10:59:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2025-04-05T14:52:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2026-04-15T02:18:00.000Z2025-04-23T16:53:00.000ZCompleted as per SOP
019 Filling Setupcompleted2025-11-30T05:23:00.000Z2025-08-12T21:59:00.000Z-
020 IPC - Fill Weight Checkcompleted2025-03-12T22:25:00.000Z2025-03-19T10:16:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010450Active Pharmaceutical Ingredient A Variant 5approvedOpen workbench
LOT-010451Active Pharmaceutical Ingredient B Variant 5approvedOpen workbench
LOT-010452Active Pharmaceutical Ingredient C Variant 5approvedOpen workbench
LOT-010453Microcrystalline Cellulose Variant 5quarantineOpen workbench
LOT-010454Lactose Monohydrate Variant 5holdOpen workbench
LOT-010455Hydroxypropyl Methylcellulose Variant 5rejectedOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01300 Laminar Flow Cabinet #301cleaning-required2026-07-05qualified
AST-01301 Isolator #302operational2026-03-10qualified
AST-01302 WFI Still #303operational2025-11-25qualified
AST-01303 RO System #304operational2026-05-07requalification-due
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check10490 to 107Pass / Pending review
API Weighing9995 to 107Pass / Pending review
IPC - Loss on Drying10395 to 102Pass / Pending review
Blending Time Verification10296 to 103Pass / Pending review
IPC - Tablet Hardness9896 to 104Pass / Pending review
IPC - Tablet Dissolution10094 to 102Pass / Pending review
Filling Setup9897 to 106Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Equipment ConflictminoropenNot linked
Equipment ConflictminoropenNot linked
Equipment Conflictminoropendev-00576
Equipment ConflictminoropenNot linked
Equipment Conflictminoropendev-01076
Equipment ConflictminoropenNot 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-020075
Score: 68
EBR completionComplete
Exceptions closedOpen
QC approvedOpen
Deviations dispositionedComplete
Calibration compliantComplete
Training confirmedOpen

Release review blocked - critical items outstanding.

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