Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities conducted for the Sterility Test Isolator/System, which is utilized for NDDS sterile applications in the microbiology area. The report includes details on the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases.

Scope/Boundaries

The scope of this validation encompasses the Sterility Test Isolator/System used for NDDS – Critical NDDS Analytics (CQA/CPP). The boundaries include all operational aspects of the system, focusing on key critical parameters such as leak integrity, airflow, and VHP cycle audit trail.

Executed Protocol List

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

Deviations Summary

No deviations were noted during the validation activities. All protocols were executed in accordance with the established procedures and acceptance criteria.

CPP Verification Summary

Key critical parameters were verified as follows:

• Leak Integrity: Complies with acceptance criteria
• Airflow: Meets specifications outlined in URS Annex1
• VHP Cycle Audit Trail: Successfully validated

Conclusion

The Sterility Test Isolator/System has been successfully validated in accordance with the established protocols and acceptance criteria outlined in URS Annex1 and Annex11. The system is deemed fit for use in NDDS sterile applications.

Attachments Index

• Attachment 1: DQ Protocol Report
• Attachment 2: IQ Protocol Report
• Attachment 3: OQ Protocol Report
• Attachment 4: PQ Protocol Report
• Attachment 5: Validation Summary Report

Approvals

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

• Quality Assurance Manager: ____________________
• Validation Manager: ____________________
• Microbiology Lead: ____________________

Requalification Frequency: 12 Months