Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities and results for the Isolator / RABS used in the production of NDDS, specifically focusing on Liposomes and Lipid Nanoparticles (LNP).

Scope and Boundaries

The scope of this validation encompasses the Isolator / RABS system used for the filling of NDDS products. The boundaries include all operational parameters, cleaning, and maintenance procedures associated with the equipment.

Executed Protocol List

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

Deviations Summary

No significant deviations were reported during the validation process. All protocols were executed according to the approved plans.

CPP Verification Summary

The following key critical parameters were verified:

• Leak integrity
• Glove integrity
• VHP cycle audit trail

All critical parameters met the acceptance criteria as referenced in URS Annex1 Annex11.

Conclusion

The validation activities for the Isolator / RABS system have been successfully completed. The equipment is qualified for use in the production of NDDS products, with a requalification frequency of 12 months.

Attachments Index

• Attachment 1: DQ Protocol and Report
• Attachment 2: IQ Protocol and Report
• Attachment 3: OQ Protocol and Report
• Attachment 4: PQ Protocol and Report
• Attachment 5: Risk Assessment Document

Approvals

This report has been reviewed and approved by the following individuals:

• _________________________ (Name, Title, Date)
• _________________________ (Name, Title, Date)