Rotary Sifter – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Summary

This Validation Summary Report provides a comprehensive overview of the validation activities conducted for the Rotary Sifter used in the Solid Dosage Form (OSD) production area. The report outlines the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, confirming that the equipment meets the defined acceptance criteria.

Scope and Boundaries

The scope of this validation encompasses the Rotary Sifter utilized in the sieving process of solid dosage forms. The boundaries include the operational and performance parameters critical to ensuring product quality and compliance with regulatory standards.

Executed Protocol List

  • DQ Protocol: Rotary Sifter Design Qualification
  • IQ Protocol: Rotary Sifter Installation Qualification
  • OQ Protocol: Rotary Sifter Operational Qualification
  • PQ Protocol: Rotary Sifter Performance Qualification

Deviations Summary

No deviations were noted during the execution of the validation protocols. All tests were performed as per the established protocols and acceptance criteria.

CPP Verification Summary

Key Critical Parameters (CPP) verified include:

  • Speed: Verified against the specified operational limits.
  • Screen Integrity: Assessed through visual inspection and functional testing.

All CPPs were found to be within acceptable limits as per the User Requirements Specification (URS).

Conclusion

The validation activities for the Rotary Sifter have been successfully completed, confirming that the equipment operates in accordance with the established acceptance criteria. The equipment is deemed qualified for use in the production of solid dosage forms.

Requalification Frequency

The requalification of the Rotary Sifter is scheduled every 24 months to ensure ongoing compliance and performance verification.

See also  Rotary Sifter – DQ Protocol

Attachments Index

  • Attachment 1: DQ Protocol Document
  • Attachment 2: IQ Protocol Document
  • Attachment 3: OQ Protocol Document
  • Attachment 4: PQ Protocol Document
  • Attachment 5: User Requirements Specification (URS)

Approvals

This Validation Summary Report has been reviewed and approved by the following personnel:

  • Quality Assurance Manager: _____________________
  • Validation Lead: _____________________
  • Production Manager: _____________________

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