Validation Summary Report (VSR) for Tablet Deduster

Summary

This Validation Summary Report outlines the validation activities performed for the Tablet Deduster used in the Solid Dosage Form (OSD) production area. The report includes details on the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases.

Scope and Boundaries

The scope of this validation encompasses the Tablet Deduster located in the Production/Compression area. The boundaries include all operational parameters and critical quality attributes associated with the dedusting process of tablets.

Executed Protocol List

DQ Protocol: Tablet Deduster DQ Report
IQ Protocol: Tablet Deduster IQ Report
OQ Protocol: Tablet Deduster OQ Report
PQ Protocol: Tablet Deduster PQ Report

Deviations Summary

No deviations were reported during the validation activities. All protocols were executed as per the planned methodology.

CPP Verification Summary

The key critical parameters verified during the validation process include:

Vibration
Airflow
Tablet Damage Assessment

All parameters met the acceptance criteria as outlined in the User Requirement Specification (URS).

Conclusion

The validation of the Tablet Deduster has been successfully completed. All qualifications (DQ/IQ/OQ/PQ) were executed and passed according to the established acceptance criteria. The equipment is deemed fit for use in the production of solid dosage forms.

Attachments Index

Attachment 1: DQ Report
Attachment 2: IQ Report
Attachment 3: OQ Report
Attachment 4: PQ Report

Approvals

Report Prepared By: ____________________

Title: ____________________

Date: ____________________

Approved By: ____________________