Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities performed for the Sterile Filtration Skid used in the production of NDDS – Liposomes & Lipid Nanoparticles (LNP). The report confirms that the equipment meets the necessary regulatory requirements and operational standards as outlined in URS Annex1 and Annex11.

Scope and Boundaries

The scope of this validation encompasses the design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of the Sterile Filtration Skid. The boundaries include all associated systems, components, and processes that directly impact the filtration of liposomes and lipid nanoparticles.

Executed Protocol List

• DQ Protocol: Sterile Filtration Skid DQ Report
• IQ Protocol: Sterile Filtration Skid IQ Report
• OQ Protocol: Sterile Filtration Skid OQ Report
• PQ Protocol: Sterile Filtration Skid PQ Report

Deviations Summary

No deviations were noted during the validation activities. All protocols were executed as planned and met the specified acceptance criteria.

CPP Verification Summary

The key critical parameters including flow, differential pressure (DP), and integrity audit trail were verified during the OQ and PQ phases. All parameters were within the defined acceptance criteria as per URS Annex1 and Annex11.

Conclusion

The validation activities for the Sterile Filtration Skid have been successfully completed, confirming that the equipment is qualified for its intended use in the production of NDDS – Liposomes & Lipid Nanoparticles (LNP). The equipment will be requalified on an annual basis as per established protocols.

Attachments Index

• Attachment 1: DQ Report
• Attachment 2: IQ Report
• Attachment 3: OQ Report
• Attachment 4: PQ Report
• Attachment 5: URS Document

Approvals

The following individuals have reviewed and approved this Validation Summary Report:

• __________________________ (Validation Manager)
• __________________________ (Quality Assurance)
• __________________________ (Production Manager)