Isolator / RABS (NDDS Filling) – Qualification Execution Checklist

Qualification Execution Checklist

Equipment: Isolator / RABS (NDDS Filling)

Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP)

Area: Production

DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes
CSV Required: Yes
Pre-start Checks





Calibration/PM Status Verification



Protocol Readiness and Approvals



Execution Controls




Review and Approvals




See also  V Blender – Equipment Validation SOP