Qualification Execution Checklist for Tangential Flow Filtration (TFF) System

Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP)

Pre-Start Checks

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

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Protocol drafted
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
QA review completed