Qualification Execution Checklist

Equipment: Sterile Filtration Skid (LVP)

Subcategory: IV Infusions (LVP/SVP – Bags/Bottles)

Area: Production

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

CSV Required: Yes

Pre-start Checks

Training completed

SOPs reviewed and approved

URS approved

Regulatory Approval obtained

Calibration/PM Status Verification

Calibration status verified

Preventive Maintenance status verified

Protocol Readiness and Approvals

Protocol finalized and approved

All necessary approvals obtained

Execution Controls

Good Documentation Practices followed

Data recording procedures in place

Deviation handling procedures established

Review and Approvals

Engineering review completed

Validation review completed

QA review completed