Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities and results for the SIP System used in the production and sterilization of ophthalmic products, specifically sterile eye drops and eye ointments. The validation process adheres to the acceptance criteria defined in URS Annex 15.

Scope/Boundaries

The scope of this validation encompasses the SIP System, including all associated tanks and lines utilized in the production and sterilization of ophthalmic formulations. The boundaries of this report include the validation phases of DQ, IQ, OQ, and PQ.

Executed Protocol List

• DQ Protocol – Document Number: DQ-001
• IQ Protocol – Document Number: IQ-001
• OQ Protocol – Document Number: OQ-001
• PQ Protocol – Document Number: PQ-001

Deviations Summary

No deviations were recorded during the validation process. All tests were executed as per the defined protocols and acceptance criteria.

CPP Verification Summary

The following key critical parameters were verified during the validation:

• Temperature: Monitored and logged continuously during operations.
• Pressure: Maintained within specified limits throughout the process.
• Hold Time: Verified against established criteria to ensure efficacy.

Conclusion

The validation of the SIP System for the production and sterilization of ophthalmic products has been successfully completed. All acceptance criteria were met, and the system is deemed compliant for use in production. Requalification is scheduled 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

Approvals

Prepared by: ______________________

Reviewed by: ______________________

Approved by: ______________________