Qualification Execution Checklist

Equipment: HEPA Integrity Test System (Photometer + Aerosol Generator)

Subcategory: Sterile (Injectables/Aseptic)

Area: Engineering

DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/No

Pre-start

Training completed
SOPs reviewed
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM status verified

Protocol Readiness and Approvals

Protocol drafted
Protocol approved

Execution Controls

GDP followed
Data recorded
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained