Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities performed for the Ultrafiltration/Diafiltration (UF/DF) Skid utilized in the development and production of NDDS – Liposomes & Lipid Nanoparticles (LNP). The report encompasses the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases.

Scope and Boundaries

The scope of this validation encompasses the UF/DF Skid used in R&D and Production environments. It includes all relevant processes, equipment, and documentation necessary for the successful operation and validation of the system.

Executed Protocol List

• DQ Protocol: UF/DF Skid DQ Document
• IQ Protocol: UF/DF Skid IQ Document
• OQ Protocol: UF/DF Skid OQ Document
• PQ Protocol: UF/DF Skid PQ Document

Deviations Summary

No deviations were recorded during the execution of the protocols. All activities were performed in accordance with the established procedures and acceptance criteria.

CPP Verification Summary

The critical process parameters (CPPs), specifically the pressure flow and membrane integrity records, were verified to be within the established acceptance criteria as defined in the URS Annex 11. All measurements were recorded and assessed for compliance.

Conclusion

All validation activities for the UF/DF Skid have been completed successfully, and the equipment is deemed qualified for use in the production of NDDS – Liposomes & Lipid Nanoparticles. The requalification frequency is established at 12 months.

Attachments Index

• Attachment 1: DQ Protocol Document
• Attachment 2: IQ Protocol Document
• Attachment 3: OQ Protocol Document
• Attachment 4: PQ Protocol Document
• Attachment 5: Pressure Flow and Membrane Integrity Records

Approvals

Prepared by: ____________________ Date: ___________

Reviewed by: ____________________ Date: ___________

Approved by: ____________________ Date: ___________