Validation Summary Report (VSR)

Summary

This Validation Summary Report provides an overview of the validation activities conducted for the Sterilization System (EO/Gamma/E-beam) used in the production of Drug-Eluting Stents and Coated Devices. The report summarizes the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities, along with the acceptance criteria and key critical parameters.

Scope and Boundaries

The scope of this validation encompasses the Sterilization System utilized in the production area for NDDS. The boundaries include the sterilization process, equipment calibration, and maintenance protocols as per URS Annex 11 and Annex 15.

Executed Protocol List

• DQ Protocol – Sterilization System
• IQ Protocol – Sterilization System
• OQ Protocol – Sterilization System
• PQ Protocol – Sterilization System

Deviations Summary

No deviations were reported during the execution of the validation protocols. All activities were performed in accordance with the established procedures and acceptance criteria.

CPP Verification Summary

The key critical parameters, specifically the cycle/dose mapping records audit trail, were verified and found to be in compliance with the defined acceptance criteria. All records were reviewed and approved as part of the validation process.

Conclusion

The validation of the Sterilization System (EO/Gamma/E-beam) for the production of Drug-Eluting Stents and Coated Devices has been successfully completed. All validation activities (DQ, IQ, OQ, PQ) were executed as per the defined protocols and acceptance criteria. The system is deemed qualified for use in production.

Attachments Index

• Attachment 1: DQ Protocol
• Attachment 2: IQ Protocol
• Attachment 3: OQ Protocol
• Attachment 4: PQ Protocol
• Attachment 5: Cycle/Dose Mapping Records

Approvals

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

• Quality Assurance Manager: ___________________
• Validation Specialist: ___________________
• Production Manager: ___________________