Validation Summary Report (VSR)

Equipment

Depyrogenation Tunnel

Subcategory

Prefilled Syringes & Cartridges

Area

Production

DQ/IQ/OQ/PQ Flags

Design Qualification (DQ): Yes

Installation Qualification (IQ): Yes

Operational Qualification (OQ): Yes

Performance Qualification (PQ): Yes

Acceptance Criteria Reference

URS Annex 15, Annex 11

Key Critical Parameters

• Temperature Profile
• Belt Speed
• Endotoxin Reduction
• PLC Logs

Requalification Frequency

12 Months

Summary

This Validation Summary Report outlines the validation activities performed for the Depyrogenation Tunnel utilized in the production of prefilled syringes and cartridges. It includes details of the executed protocols, deviations, critical process parameter verification, and overall conclusions regarding the equipment’s performance and compliance.

Scope/Boundaries

The scope of this validation encompasses the design, installation, operational, and performance qualifications of the Depyrogenation Tunnel. It is limited to the production area where prefilled syringes and cartridges are processed, ensuring compliance with regulatory standards.

Executed Protocol List

• Design Qualification Protocol
• Installation Qualification Protocol
• Operational Qualification Protocol
• Performance Qualification Protocol

Deviations Summary

No significant deviations were reported during the validation process. All parameters were within the acceptance criteria as outlined in URS Annex 15 and Annex 11.

CPP Verification Summary

All critical process parameters were verified and documented, ensuring that temperature profiles, belt speeds, endotoxin reduction levels, and PLC logs met the established acceptance criteria.

Conclusion

The Depyrogenation Tunnel has been successfully validated for use in the production of prefilled syringes and cartridges. The equipment meets all regulatory requirements and acceptance criteria, confirming its suitability for intended use.

Attachments Index

• Executed Protocols
• Raw Data Reports
• Calibration Certificates
• Deviation Reports

Approvals

Prepared by: [Name]

Reviewed by: [Name]

Approved by: [Name]