Qualification Execution Checklist

Equipment: Sterilization System (EO/Gamma/E-beam)

Subcategory: NDDS – Drug-Eluting Stents / Coated Devices

Area: Production

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

CSV Required: Yes

Pre-start

Training completed
SOPs approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM status verified

Protocol Readiness and Approvals

Protocol ready for execution
Approvals obtained

Execution Controls

GDP adherence confirmed
Data recording procedures followed
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained

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