Validation Summary Report (VSR)

Summary

This Validation Summary Report provides an overview of the validation activities conducted for the Leak Test Machine used in the production and quality control of nasal and otic products, both sterile and non-sterile.

Scope/Boundaries

The scope of this validation encompasses the Leak Test Machine utilized for the detection of leaks in container closures. This validation applies to both sterile and non-sterile nasal and otic products produced in the Production/QC area.

Executed Protocol List

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

Deviations Summary

No deviations were recorded during the execution of the validation protocols.

CPP Verification Summary

The key critical parameter for the Leak Test Machine is the leak detection sensitivity. An audit trail was established to ensure compliance with the acceptance criteria outlined in the URS Annex 11.

Conclusion

Based on the executed validation protocols and the absence of deviations, the Leak Test Machine is deemed qualified for use in the production of nasal and otic products. The requalification frequency is set at 12 months.

Attachments Index

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

Approvals

Approved by: [Name], [Title]

Date: [Date]