Lipid Melting / Lipid Preparation Vessel Qualification Execution Checklist
Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP)
Area: R&D/Production
DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes
CSV Required: Yes
Pre-start
- Training completed for all personnel
- Standard Operating Procedures (SOPs) reviewed and approved
- User Requirements Specification (URS) approved
- Regulatory Affairs (RA) approval obtained
Calibration/PM Status Verification
- Calibration status verified
- Preventive Maintenance (PM) records reviewed
Protocol Readiness and Approvals
- Qualification protocol drafted
- Protocol reviewed and approved by Engineering
- Protocol reviewed and approved by Validation
- Protocol reviewed and approved by QA
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
- QA review completed