Batch BT-020049

Corazyme • DRH • L050 • 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
2025-01-12 → 2025-01-21
Actual
Pending → In progress
Exceptions
19
Release Risk
low
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2026-05-16T02:23:00.000Z2025-12-11T14:25:00.000Z-
002 Dispensing Startcompleted2026-05-17T12:45:00.000Z2025-12-19T20:49:00.000ZCompleted as per SOP
003 API Weighingin-progress2026-12-12T11:04:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2026-07-13T13:44:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2026-03-29T18:52:00.000Z2026-05-02T02:15:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2026-01-09T01:46:00.000Z2025-11-06T22:15:00.000Z-
008 Blending Startcompleted2025-01-24T21:33:00.000Z2025-08-09T06:13:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2026-09-12T22:52:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2026-05-08T07:40:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2025-02-08T05:30:00.000Z2026-01-18T21:27:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2026-03-23T19:49:00.000Z2025-05-11T11:47:00.000Z-
014 IPC - Tablet Friabilitycompleted2026-10-15T15:27:00.000Z2025-09-27T22:10:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2025-02-28T22:39:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2025-11-29T21:20:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2026-05-12T12:31:00.000Z2026-08-16T18:20:00.000ZCompleted as per SOP
019 Filling Setupcompleted2026-03-12T03:54:00.000Z2025-07-12T04:39:00.000Z-
020 IPC - Fill Weight Checkcompleted2026-05-31T22:19:00.000Z2026-03-24T14:44:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010245Hydroxypropyl Methylcellulose Variant 8approvedOpen workbench
LOT-010246Magnesium Stearate Variant 8quarantineOpen workbench
LOT-010247Croscarmellose Sodium Variant 8holdOpen workbench
LOT-010248Povidone K30 Variant 8rejectedOpen workbench
LOT-010249Talc Variant 8expiredOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01098 Particle Size Analyzer #99operational2025-09-27requalification-due
AST-01099 Microscope #100operational2026-03-30not-qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check10290 to 108Pass / Pending review
API Weighing10496 to 107Pass / Pending review
IPC - Loss on Drying9994 to 109Pass / Pending review
Blending Time Verification10397 to 103Pass / Pending review
IPC - Tablet Hardness9893 to 103Pass / Pending review
IPC - Tablet Dissolution9994 to 107Pass / Pending review
Filling Setup10396 to 110Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Missing SignatureminorclosedNot linked
Missing SignatureminorclosedNot linked
Missing SignatureminorclosedNot linked
Missing SignatureminorclosedNot linked
Missing Signatureminorcloseddev-01050
Missing SignatureminorclosedNot 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-020049
Score: 65
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.