Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities performed for the Double Cone Blender utilized in the Solid Dosage Form (OSD) production area. The equipment has undergone Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure compliance with the User Requirement Specification (URS).

Scope and Boundaries

The scope of this validation encompasses the Double Cone Blender used for blending solid dosage forms in the production area. The boundaries include the equipment setup, operation, and maintenance procedures, as well as the associated documentation.

Executed Protocol List

• DQ Protocol – Double Cone Blender
• IQ Protocol – Double Cone Blender
• OQ Protocol – Double Cone Blender
• PQ Protocol – Double Cone Blender

Deviations Summary

No significant deviations were noted during the execution of the validation protocols. All acceptance criteria were met as outlined in the URS.

CPP Verification Summary

The key critical parameters identified for the Double Cone Blender include:

• RPM: Verified against the specified limits.
• Blending Time: Confirmed to meet the required duration for effective blending.

Conclusion

The Double Cone Blender has been successfully validated for use in the Solid Dosage Form production area. The equipment meets all specified acceptance criteria and is deemed suitable for its intended purpose. Requalification is scheduled every 24 months.

Attachments Index

• Attachment 1: DQ Protocol Document
• Attachment 2: IQ Protocol Document
• Attachment 3: OQ Protocol Document
• Attachment 4: PQ Protocol Document

Approvals

Approved by:

• Name: ________________________ Signature: ________________________ Date: ________________
• Name: ________________________ Signature: ________________________ Date: ________________