Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities and outcomes for the Syringe Stoppering Machine used in the production of prefilled syringes and cartridges. The report confirms that the equipment meets the requirements set forth in the User Requirements Specification (URS) Annex 11.

Scope and Boundaries

The scope of this validation includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the Syringe Stoppering Machine. The boundaries of this validation are limited to the operational parameters and performance metrics defined in the URS.

Executed Protocol List

• Design Qualification Protocol (DQP)
• Installation Qualification Protocol (IQP)
• Operational Qualification Protocol (OQP)
• Performance Qualification Protocol (PQP)

Deviations Summary

No significant deviations were recorded during the validation process. All activities were completed in accordance with the approved protocols.

CPP Verification Summary

The key critical parameter (CPP) for this validation, which is the stopper placement reject logic audit trail logs, was verified successfully throughout the qualification phases. All logs were found to be in compliance with predefined acceptance criteria.

Conclusion

The validation of the Syringe Stoppering Machine has been successfully completed. The equipment is qualified for use in the production of prefilled syringes and cartridges, with a requalification frequency of 12 months as specified.

Attachments Index

• Attachment 1: Design Qualification Report
• Attachment 2: Installation Qualification Report
• Attachment 3: Operational Qualification Report
• Attachment 4: Performance Qualification Report

Approvals

Prepared by: [Name], [Title]

Date: [Date]

Approved by: [Name], [Title]

Date: [Date]