Qualification Execution Checklist

Equipment: Leak Test Machine (CCIT)

Subcategory: Prefilled Syringes & Cartridges

Area: Production/QC

DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes

CSV Required: Yes

Pre-Start Checks

Training completed
SOPs reviewed and approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM completed

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

GDP adhered to
Data recording completed
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained

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