Qualification Execution Checklist

Equipment: Ultrasonicator (Probe/Bath)

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
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
Preventive maintenance completed

Protocol Readiness and Approvals

Protocol finalized
Protocol approved by all stakeholders

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
QA review completed