Validation Summary Report (VSR)

Summary

This Validation Summary Report documents the validation activities performed on the Cartoning Machine used for Solid Dosage Forms in the Packaging/Secondary area. The report outlines the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes conducted to ensure compliance with regulatory standards.

Scope/Boundaries

The scope of this validation encompasses the Cartoning Machine utilized for packaging solid dosage forms. The boundaries include the machine’s operational parameters, software functionalities, and integration with other packaging equipment. The validation activities are aligned with the User Requirement Specification (URS) Annex 11.

Executed Protocol List

Design Qualification Protocol (DQP)
Installation Qualification Protocol (IQP)
Operational Qualification Protocol (OQP)
Performance Qualification Protocol (PQP)

Deviations Summary

No deviations were recorded during the validation activities. All testing was completed as per the approved protocols.

CPP Verification Summary

The key critical parameters verified include:

Leaflet detection
Reject logic
Speed audit trail

All parameters were found to be within acceptable limits as defined in the URS Annex 11.

Conclusion

The Cartoning Machine has successfully met all validation criteria as outlined in the DQ, IQ, OQ, and PQ protocols. It is recommended for routine use in the Packaging/Secondary area with a requalification frequency of 12 months.

Attachments Index

Attachment 1: Design Qualification Report
Attachment 2: Installation Qualification Report
Attachment 3: Operational Qualification Report
Attachment 4: Performance Qualification Report

Approvals

Prepared by: ____________________

Date: ____________________

Approved by: ____________________