Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities conducted for the Labeling Machine used in the packaging of IV Infusions (LVP/SVP – Bags/Bottles). The report summarizes the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, confirming that the equipment meets the specified acceptance criteria as per URS Annex 11.

Scope and Boundaries

The scope of this validation includes the Labeling Machine utilized in the Packaging/Primary area for IV Infusions. The boundaries of the validation encompass all relevant processes, equipment, and documentation associated with the labeling operations.

Executed Protocol List

• Design Qualification (DQ) Protocol – [Document Number]
• Installation Qualification (IQ) Protocol – [Document Number]
• Operational Qualification (OQ) Protocol – [Document Number]
• Performance Qualification (PQ) Protocol – [Document Number]

Deviations Summary

No significant deviations were noted during the validation process. All activities were executed as per the established protocols and acceptance criteria.

CPP Verification Summary

The following key critical parameters were verified:

• Placement accuracy
• Print verification
• Audit trail

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

Conclusion

The validation of the Labeling Machine for IV Infusions (LVP/SVP – Bags/Bottles) has been successfully completed. The machine has been qualified according to DQ, IQ, OQ, and PQ protocols, demonstrating compliance with all critical parameters and acceptance criteria. Requalification is scheduled every 12 months.

Attachments Index

• Attachment 1: DQ Protocol
• Attachment 2: IQ Protocol
• Attachment 3: OQ Protocol
• Attachment 4: PQ Protocol
• Attachment 5: Validation Summary Report

Approvals

This report has been reviewed and approved by:

• [Name], [Title], [Date]
• [Name], [Title], [Date]