Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities performed for the Implant Packaging Machine used in the packaging of drug-eluting and biodegradable implants. The report encompasses the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, ensuring compliance with URS Annex 11.

Scope/Boundaries

The scope of this validation encompasses the entire packaging process for drug-eluting and biodegradable implants. It includes the evaluation of the machine’s performance, the verification of critical parameters, and the establishment of a requalification frequency of 12 months.

Executed Protocol List

• DQ Protocol
• IQ Protocol
• OQ Protocol
• PQ Protocol

Deviations Summary

No deviations were noted during the execution of the validation protocols. All validation activities were completed as per the established protocols.

CPP Verification Summary

The key critical parameters verified during the validation include:

• Sealing integrity audit trail logs

All critical parameters met the acceptance criteria as outlined in the URS Annex 11.

Conclusion

The validation of the Implant Packaging Machine has been successfully completed. All qualifications (DQ, IQ, OQ, PQ) have been executed according to the protocols, and the machine is deemed compliant for use in the packaging of drug-eluting and biodegradable implants. The requalification frequency is established at 12 months.

Attachments Index

• Attachment 1: DQ Protocol Document
• Attachment 2: IQ Protocol Document
• Attachment 3: OQ Protocol Document
• Attachment 4: PQ Protocol Document

Approvals

Prepared by: ____________________

Reviewed by: ____________________

Approved by: ____________________