Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities performed for the Coding Machine utilized in the packaging of sterile powders and lyophilized products. The report encompasses all phases of validation, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Scope and Boundaries

The scope of this validation encompasses the Coding Machine used for labeling sterile powders and lyophilized products in the packaging area. The boundaries include all operational parameters, maintenance procedures, and compliance with URS Annex 11.

Executed Protocol List

• DQ Protocol – Coding Machine
• IQ Protocol – Coding Machine
• OQ Protocol – Coding Machine
• PQ Protocol – Coding Machine

Deviations Summary

No significant deviations were noted during the validation activities. All protocols were executed as per the approved procedures.

CPP Verification Summary

The key critical parameter verified during the PQ phase was the print quality audit trail logs. All logs were reviewed and confirmed to meet the acceptance criteria as specified in the URS Annex 11.

Conclusion

The validation of the Coding Machine has been successfully completed. All acceptance criteria have been met, and the equipment is deemed suitable for use in the packaging of sterile powders and lyophilized products. Requalification is scheduled for every 12 months.

Attachments Index

• Attachment 1: DQ Protocol Report
• Attachment 2: IQ Protocol Report
• Attachment 3: OQ Protocol Report
• Attachment 4: PQ Protocol Report
• Attachment 5: Audit Trail Logs

Approvals

This report has been reviewed and approved by:

• Quality Assurance: ____________________
• Validation Manager: ____________________
• Operations Manager: ____________________