Split Butterfly Valve (SBV) Transfer System – Validation Summary Report (VSR) Template

Validation Summary Report

Equipment: Split Butterfly Valve (SBV) Transfer System

Subcategory: Solid Dosage Form (OSD)

Area: Production/Containment

Summary

This Validation Summary Report (VSR) documents the validation activities performed on the Split Butterfly Valve (SBV) Transfer System, confirming compliance with the User Requirements Specification (URS) and ensuring that the system meets the necessary regulatory standards.

Scope/Boundaries

The scope of this validation encompasses the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the SBV Transfer System. The validation activities are limited to the production and containment areas where the system will be utilized.

Executed Protocol List

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

Deviations Summary

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

CPP Verification Summary

The key critical parameter verified during the validation was the containment seal integrity docking. The results confirmed that the seal integrity meets the acceptance criteria as outlined in the URS.

Conclusion

The Split Butterfly Valve (SBV) Transfer System has been successfully validated, demonstrating compliance with the URS and the required qualification protocols. The system is approved for use in solid dosage form production and containment.

Requalification Frequency

The requalification of the SBV Transfer System is scheduled every 24 months to ensure continued compliance and performance.

Attachments Index

  • Attachment 1: DQ Protocol Document
  • Attachment 2: IQ Protocol Document
  • Attachment 3: OQ Protocol Document
  • Attachment 4: PQ Protocol Document
See also  Contained Transfer Port (RTP-like) – Qualification Certificate Template

Approvals

This validation summary report has been reviewed and approved by the following personnel:

  • Validated by: [Name, Title]
  • Reviewed by: [Name, Title]
  • Approved by: [Name, Title]

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