Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities performed for the Coding/Printing Machine (Inkjet/Laser) utilized in the packaging of IV Infusions (LVP/SVP – Bags/Bottles). The report provides an overview of the validation process, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.

Scope and Boundaries

The scope of this validation encompasses the Coding/Printing Machine used for labeling IV Infusions in the Packaging/Primary area. The boundaries include all aspects of the equipment’s operation, from setup to routine use, ensuring compliance with URS Annex11 acceptance criteria.

Executed Protocol List

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

Deviations Summary

No deviations were recorded during the validation process. All protocols were executed as planned, adhering to the specified acceptance criteria.

CPP Verification Summary

The key critical parameter verified during the validation process was the print quality verification audit trail. All print quality checks were documented, and results met the acceptance criteria outlined in the URS Annex11.

Conclusion

The validation activities for the Coding/Printing Machine (Inkjet/Laser) have been successfully completed. The equipment has been demonstrated to operate within specified parameters, ensuring compliance with regulatory requirements and the quality standards for IV Infusions packaging.

Attachments Index

• Attachment 1: DQ Protocol
• Attachment 2: IQ Protocol
• Attachment 3: OQ Protocol
• Attachment 4: PQ Protocol
• Attachment 5: Print Quality Audit Trail

Approvals

Prepared by: [Name], [Title], [Date]

Reviewed by: [Name], [Title], [Date]

Approved by: [Name], [Title], [Date]