Validation Summary Report (VSR)

Equipment: Nitrogen Purging System

Subcategory: Prefilled Syringes & Cartridges

Area: Production

Summary

This Validation Summary Report (VSR) provides an overview of the validation activities conducted for the Nitrogen Purging System utilized in the production of prefilled syringes and cartridges. The validation process adhered to the guidelines set forth in URS Annex 11 and included Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Scope and Boundaries

The scope of this validation encompasses the Nitrogen Purging System used in the production area for prefilled syringes and cartridges. It includes all relevant equipment, processes, and personnel involved in the operation and maintenance of the system.

Executed Protocol List

• DQ Protocol – Nitrogen Purging System
• IQ Protocol – Nitrogen Purging System
• OQ Protocol – Nitrogen Purging System
• PQ Protocol – Nitrogen Purging System

Deviations Summary

No deviations were recorded during the validation process. All protocols were executed as planned, and acceptance criteria were met.

CPP Verification Summary

Key critical parameters were verified, including nitrogen purity and flow audit trail logs. All parameters were found to be within acceptable limits as specified in the URS Annex 11.

Conclusion

The validation of the Nitrogen Purging System has been successfully completed. All qualification activities (DQ, IQ, OQ, PQ) were executed in compliance with the established protocols and acceptance criteria. The system is deemed qualified for use in the production of prefilled syringes and cartridges, with a requalification frequency of 12 months.

Attachments Index

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

Approvals

Prepared by: [Name], [Title]

Approved by: [Name], [Title]