Isolator / RABS System – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities performed for the Isolator / RABS System used in the production of prefilled syringes and cartridges. The report includes details on the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, confirming compliance with URS Annex 1 and Annex 11 acceptance criteria.

Scope/Boundaries

The scope of this validation encompasses the Isolator / RABS System utilized in the production area for prefilled syringes and cartridges. All critical parameters related to pressure integrity and VHP cycle audit trail logs are included in the validation process.

Executed Protocol List

  • DQ Protocol – Isolator / RABS System
  • IQ Protocol – Isolator / RABS System
  • OQ Protocol – Isolator / RABS System
  • PQ Protocol – Isolator / RABS System

Deviations Summary

No deviations were noted during the validation activities. All protocols were executed as per the approved plans and specifications.

CPP Verification Summary

The critical process parameters (CPPs) related to pressure integrity and VHP cycle audit trail logs were verified and found to be within the acceptance criteria defined in the URS. All parameters were continuously monitored and documented throughout the validation process.

Conclusion

The validation activities for the Isolator / RABS System have been successfully completed, demonstrating that the system meets all specified requirements. The system is validated for continued use in the production of prefilled syringes and cartridges, with a requalification frequency of 12 months.

Attachments Index

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

This report has been reviewed and approved by:

  • Quality Assurance: [Name, Title, Date]
  • Validation Manager: [Name, Title, Date]
  • Production Manager: [Name, Title, Date]

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