Qualification Execution Checklist

Equipment: Inline Static Mixer

Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP)

Area: R&D/Production

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

Pre-start

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

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Protocol prepared
Protocol approved by relevant stakeholders

Execution Controls

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

Review and Approvals

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