Qualification Execution Checklist for Terminal HEPA Filters

Equipment: Terminal HEPA Filters

Subcategory: Sterile (Injectables/Aseptic)

Area: Engineering

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

Pre-start

Training completed
SOPs reviewed and approved
URS approved
Regulatory Approval (RA) obtained

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

Good Documentation Practices (GDP) followed
Data recording completed
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed