Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities performed for the Roller Compactor used in the Production/Dry Granulation area for Solid Dosage Forms (OSD). The report includes details on the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, along with acceptance criteria and critical parameters.

Scope and Boundaries

The scope of this validation encompasses the Roller Compactor utilized in the production of solid dosage forms, specifically focusing on the dry granulation process. The boundaries include all operational and functional aspects of the equipment as defined in the User Requirement Specification (URS) Annex 11.

Executed Protocol List

• DQ Protocol
• IQ Protocol
• OQ Protocol
• PQ Protocol

Deviations Summary

During the validation process, no significant deviations were observed that would impact the integrity of the validation outcomes. All protocols were executed as per the defined procedures.

CPP Verification Summary

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

• Roll Pressure
• Gap
• Speed
• Feed Rate
• PLC

All parameters met the acceptance criteria as outlined in the URS Annex 11.

Conclusion

Based on the executed validation protocols, the Roller Compactor has been successfully validated for use in the Production/Dry Granulation area for solid dosage forms. The equipment is deemed suitable for its intended use and meets all specified acceptance criteria. The requalification frequency is set at 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

This document has been reviewed and approved by the following individuals:

• Quality Assurance Manager: [Name]
• Validation Lead: [Name]
• Production Manager: [Name]