Batch BT-020079

Corazyme • CMO2 • L030 • 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
2024-12-30 → 2025-01-03
Actual
Pending → In progress
Exceptions
22
Release Risk
low
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2026-07-16T16:21:00.000Z2025-08-14T06:51:00.000Z-
002 Dispensing Startcompleted2026-08-16T07:43:00.000Z2025-11-04T18:34:00.000ZCompleted as per SOP
003 API Weighingin-progress2025-12-16T11:01:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2026-10-21T22:10:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2025-11-17T21:31:00.000Z2026-05-07T07:46:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2025-01-21T10:02:00.000Z2026-11-01T11:17:00.000Z-
008 Blending Startcompleted2025-01-11T18:08:00.000Z2025-10-31T04:02:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2026-12-06T23:25:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2025-10-11T19:53:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2026-03-16T14:28:00.000Z2025-06-28T00:18:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2026-07-26T00:10:00.000Z2025-09-13T18:01:00.000Z-
014 IPC - Tablet Friabilitycompleted2025-04-16T03:01:00.000Z2026-07-03T06:09:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2025-02-05T03:06:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2026-11-05T07:59:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2026-09-26T12:25:00.000Z2025-03-16T00:59:00.000ZCompleted as per SOP
019 Filling Setupcompleted2025-05-16T23:17:00.000Z2026-01-04T01:23:00.000Z-
020 IPC - Fill Weight Checkcompleted2025-05-01T09:38:00.000Z2025-09-03T14:58:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010316SucroseapprovedOpen workbench
LOT-010317TrehaloseapprovedOpen workbench
LOT-010318Histidine BufferquarantineOpen workbench
LOT-010319Sodium ChlorideholdOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01316 Metal Detector #317operational2026-01-11qualified
AST-01317 X-Ray Inspection #318operational2025-07-19qualified
AST-01318 Leak Tester #319in-calibration2026-02-08requalification-due
AST-01319 Torque Tester #320in-maintenance2026-03-01not-qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check10598 to 103Pass / Pending review
API Weighing9995 to 110Pass / Pending review
IPC - Loss on Drying10394 to 105Pass / Pending review
Blending Time Verification10290 to 107Pass / Pending review
IPC - Tablet Hardness10293 to 108Pass / Pending review
IPC - Tablet Dissolution9892 to 104Pass / Pending review
Filling Setup10494 to 103Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
System ErrorminorclosedNot linked
System Errorminorcloseddev-01080
System ErrorminorclosedNot linked
System ErrorminorclosedNot linked
System ErrorminorclosedNot linked
System ErrorminorclosedNot 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-020079
Score: 88
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.