Qualification Execution Checklist

Equipment: Extrusion System (Liposome Extruder)

Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP)

Area: R&D/Production

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

CSV Required: Yes

Pre-start Checks

Training completed
SOPs reviewed and approved
User Requirement Specification (URS) approved
Regulatory Affairs (RA) approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocol finalized
Protocol approvals obtained

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures in place
Deviations documented and managed

Review and Approvals

Engineering review completed
Validation review completed
Quality Assurance (QA) review completed

Final Review

All documentation complete and accurate
Final approval obtained