Validation Summary Report for CIP Skid

Summary

This Validation Summary Report (VSR) outlines the validation activities performed on the CIP Skid used for the production and cleaning of Nasal & Otic Products. The report confirms that the equipment meets the specified requirements and is compliant with URS Annex 11 and Annex 15.

Scope and Boundaries

The scope of this validation includes the installation, operational, and performance qualifications of the CIP Skid within the Production and Cleaning areas. The boundaries of this validation encompass all critical parameters affecting the cleaning and sterilization processes.

Executed Protocol List

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

Deviations Summary

No significant deviations were noted during the validation process. All protocols were executed as planned, and any minor observations were documented and addressed in accordance with standard operating procedures.

CPP Verification Summary

The following key critical parameters were verified during the validation process:

• Temperature
• Conductivity
• Flow
• Audit Trail Logs

All parameters were found to be within the acceptance criteria as per the URS and were deemed acceptable for operation.

Conclusion

The CIP Skid has been successfully validated for use in the production and cleaning of Nasal & Otic Products. The equipment meets all specified requirements and is compliant with regulatory standards. Requalification is scheduled for every 12 months.

Attachments Index

• Attachment 1: DQ Protocol
• Attachment 2: IQ Protocol
• Attachment 3: OQ Protocol
• Attachment 4: PQ Protocol
• Attachment 5: Deviations Log
• Attachment 6: CPP Verification Records

Approvals

This report has been reviewed and approved by the following personnel:

• Quality Assurance Manager: ____________________
• Validation Manager: ____________________
• Production Manager: ____________________