Validation Summary Report (VSR)
Equipment: Vibro Sifter
Subcategory: Solid Dosage Form (OSD)
Area: Production/Sieving
1. Summary
This Validation Summary Report outlines the validation activities conducted for the Vibro Sifter used in the production of solid dosage forms. The report includes details on the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases.
2. Scope/Boundaries
The scope of this validation encompasses the Vibro Sifter utilized in the sieving process within the production area. All critical parameters, including screen integrity and RPM vibration, have been assessed in accordance with the User Requirements Specification (URS).
3. Executed Protocol List
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
4. Deviations Summary
There were no deviations noted during the validation process. All activities were performed in compliance with the established protocols and acceptance criteria.
5. CPP Verification Summary
The following critical parameters were verified:
- Screen Integrity: Passed
- RPM Vibration: Within acceptable limits
6. Conclusion
The Vibro Sifter has successfully met all validation requirements as per the DQ, IQ, OQ, and PQ protocols. The equipment is deemed fit for its intended use in the production of solid dosage forms.
7. Requalification Frequency
Requalification of the Vibro Sifter is scheduled every 24 months to ensure continued compliance and performance.
8. Attachments Index
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Maintenance Records
9. Approvals
This report has been reviewed and approved by the following personnel:
- Quality Assurance Manager: ___________________
- Validation Manager: ___________________
- Production Manager: ___________________