Batch BT-020008

Pulmozide • NWK • L009 • rejected

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
2025-10-25 → 2025-11-06
Actual
2025-03-20 → 2025-11-05
Exceptions
6
Release Risk
medium
Step Timeline
StepStatusStartEndResult
001 Line Clearance Checkcompleted2026-09-07T06:49:00.000Z2026-05-12T17:11:00.000Z-
002 Dispensing Startcompleted2026-12-02T03:27:00.000Z2025-05-10T20:28:00.000ZCompleted as per SOP
003 API Weighingin-progress2025-07-03T23:09:00.000Z--
004 Excipient Weighingpending---
005 Granulation Startexception2026-07-29T03:45:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
006 Granulation End Weightcompleted2026-04-05T00:34:00.000Z2026-05-23T19:05:00.000ZCompleted as per SOP
007 IPC - Loss on Dryingcompleted2025-11-14T23:24:00.000Z2025-07-26T03:28:00.000Z-
008 Blending Startcompleted2025-06-20T15:25:00.000Z2026-12-27T16:37:00.000ZCompleted as per SOP
009 Blending Time Verificationin-progress2025-09-02T07:09:00.000Z--
010 IPC - Blend Uniformitypending---
011 Compression Setupexception2025-02-09T22:15:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
012 IPC - Tablet Weightcompleted2026-12-07T09:40:00.000Z2025-01-02T03:17:00.000ZCompleted as per SOP
013 IPC - Tablet Hardnesscompleted2026-03-17T22:48:00.000Z2025-08-14T02:04:00.000Z-
014 IPC - Tablet Friabilitycompleted2025-10-21T11:05:00.000Z2026-04-09T16:05:00.000ZCompleted as per SOP
015 IPC - Tablet Dissolutionin-progress2026-10-21T23:30:00.000Z--
016 Film Coating Setuppending---
017 IPC - Coating Weight Gainexception2025-11-20T07:59:00.000Z-Value out of specification: undefined (spec: undefined-undefined)
018 IPC - Tablet Appearancecompleted2026-10-10T18:15:00.000Z2025-08-19T08:26:00.000ZCompleted as per SOP
019 Filling Setupcompleted2026-01-21T22:14:00.000Z2026-03-08T02:45:00.000Z-
020 IPC - Fill Weight Checkcompleted2025-05-07T13:26:00.000Z2025-11-17T11:20:00.000ZCompleted as per SOP
Materials Consumed and Genealogy
LotMaterialStatusGenealogy
LOT-010056Methanol HPLC Grade Variant 1approvedOpen workbench
LOT-010057Hydrochloric Acid 37% Variant 1quarantineOpen workbench
LOT-010058Sodium Hydroxide Variant 1holdOpen workbench
LOT-010059Phosphoric Acid Variant 1rejectedOpen workbench
LOT-010060Active Pharmaceutical Ingredient A Variant 2expiredOpen workbench
LOT-010061Active Pharmaceutical Ingredient B Variant 2consumedOpen workbench
LOT-010062Active Pharmaceutical Ingredient C Variant 2in-processOpen workbench
Equipment and Calibration
AssetStatusCalibration DueQualification
AST-01024 Compressed Air System #25in-calibration2025-01-26not-qualified
AST-01025 HVAC Unit #26in-maintenance2026-03-31qualified
AST-01026 Refrigerator #27out-of-service2026-03-19qualified
In-Process Controls and Pending Tests
ControlMeasuredSpecStatus
Line Clearance Check9893 to 103Pass / Pending review
API Weighing10094 to 106Pass / Pending review
IPC - Loss on Drying10596 to 105Pass / Pending review
Blending Time Verification9891 to 110Pass / Pending review
IPC - Tablet Hardness10294 to 102Pass / Pending review
IPC - Tablet Dissolution10190 to 108Pass / Pending review
Filling Setup10391 to 102Pass / Pending review
Exceptions and Deviations
ExceptionSeverityStatusDeviation
Out of SpecificationminorclosedNot linked
Out of SpecificationminorclosedNot linked
Out of SpecificationminorclosedNot linked
Out of SpecificationminorclosedNot linked
Out of Specificationminorcloseddev-01009
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-020008
Score: 87
EBR completionComplete
Exceptions closedOpen
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.