Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities conducted for the Twin Screw Extruder used in the production of solid dosage forms (OSD) in the pellet area. The report includes the executed protocols, deviations, critical parameter verifications, and concludes with the overall validation status.

Scope and Boundaries

The scope of this validation encompasses the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the Twin Screw Extruder. The boundaries include all operational aspects relevant to the production of pellets in the OSD area.

Executed Protocol List

• DQ Protocol – Twin Screw Extruder
• IQ Protocol – Twin Screw Extruder
• OQ Protocol – Twin Screw Extruder
• PQ Protocol – Twin Screw Extruder

Deviations Summary

No deviations were recorded during the validation process. All activities were performed as per the approved protocols.

CPP Verification Summary

The following key critical parameters were verified as part of the validation:

• Screw Speed
• Temperature Zones
• Torque

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

Conclusion

The validation activities for the Twin Screw Extruder have been successfully completed. The equipment has been qualified for use in the production of solid dosage forms, and all critical parameters have been verified. The requalification frequency is set for 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

This report has been reviewed and approved by:

• ____________________ – Validation Manager
• ____________________ – Quality Assurance
• ____________________ – Production Lead