Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities conducted for the Tablet Compression Machine (Double Rotary) used in the Solid Dosage Form (OSD) production area. The validation process includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as per the acceptance criteria outlined in URS Annex11.

Scope/Boundaries

The scope of this validation encompasses the installation and operational performance of the Tablet Compression Machine within the Production/Compression area. It includes the assessment of all critical parameters related to the equipment’s functionality and compliance with regulatory standards.

Executed Protocol List

• DQ Protocol: Completed
• IQ Protocol: Completed
• OQ Protocol: Completed
• PQ Protocol: Completed

Deviations Summary

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

CPP Verification Summary

The following key critical parameters were verified during the qualification process:

• Speed: Verified
• Force: Verified
• Weight Control: Verified
• Reject: Verified

Conclusion

The Tablet Compression Machine (Double Rotary) has successfully passed all validation phases (DQ, IQ, OQ, PQ) and is deemed compliant with the acceptance criteria specified in URS Annex11. It is recommended for use in production with a requalification frequency of 12 months.

Attachments Index

• Attachment 1: DQ Protocol Document
• Attachment 2: IQ Protocol Document
• Attachment 3: OQ Protocol Document
• Attachment 4: PQ Protocol Document
• Attachment 5: Validation Summary Report

Approvals

Prepared by: [Name], [Title]

Reviewed by: [Name], [Title]

Approved by: [Name], [Title]