Qualification Execution Checklist for AHU in Aseptic Area

Equipment Details

• Equipment: AHU for Aseptic Area
• Subcategory: Sterile (Injectables/Aseptic)
• Area: Engineering
• DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes
• CSV Required: Yes

Pre-Start Checks

• Training Completed
• SOPs Reviewed
• URS Approved
• Regulatory Approval Obtained

Calibration/PM Status Verification

• Calibration Status Verified
• PM Status Verified

Protocol Readiness and Approvals

• Protocol Ready for Execution
• All Approvals Obtained

Execution Controls

• Good Documentation Practices Followed
• Data Recording Procedures Followed
• Deviations Documented

Review and Approvals

• Engineering Review Completed
• Validation Review Completed
• QA Review Completed