Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities conducted for the Filter Integrity Tester used in the production and quality control of prefilled syringes and cartridges. The report covers the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, ensuring compliance with regulatory requirements and internal standards.

Scope/Boundaries

The scope of this validation encompasses the Filter Integrity Tester utilized in the Production/QC area for the testing of prefilled syringes and cartridges. The validation activities include all relevant documentation and procedures associated with the equipment’s operation, maintenance, and quality assurance.

Executed Protocol List

• Design Qualification (DQ) Protocol – Document No. DQ-001
• Installation Qualification (IQ) Protocol – Document No. IQ-001
• Operational Qualification (OQ) Protocol – Document No. OQ-001
• Performance Qualification (PQ) Protocol – Document No. PQ-001

Deviations Summary

No significant deviations were encountered during the validation process. All activities were performed in accordance with the established protocols and acceptance criteria as outlined in the URS Annex 11.

CPP Verification Summary

The key critical parameters, specifically the bubble point diffusion audit trail logs, were verified and found to be within the established acceptance criteria. Continuous monitoring and documentation were maintained throughout the validation process.

Conclusion

The Filter Integrity Tester has been successfully validated for use in the production and quality control of prefilled syringes and cartridges. The equipment meets all defined acceptance criteria and is compliant with regulatory requirements. Requalification is scheduled every 12 months to ensure ongoing compliance and performance.

Attachments Index

• Attachment 1: DQ Protocol Report
• Attachment 2: IQ Protocol Report
• Attachment 3: OQ Protocol Report
• Attachment 4: PQ Protocol Report
• Attachment 5: Audit Trail Logs

Approvals

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

• Quality Assurance Manager: ____________________ Date: __________
• Production Manager: _________________________ Date: __________
• Validation Lead: ___________________________ Date: __________