Validation Summary Report (VSR)

Equipment: Sterilizing Autoclave (Components)

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Production

Summary

This Validation Summary Report outlines the validation activities conducted for the Sterilizing Autoclave used in the production of sterile ophthalmic products, including eye drops and eye ointments. The report covers the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases.

Scope/Boundaries

The scope of this validation encompasses the Sterilizing Autoclave utilized in the production area for ophthalmics. The boundaries of the validation include the equipment functionality, critical parameters, and compliance with URS Annex 15 and Annex 11 guidelines.

Executed Protocol List

• DQ Protocol – Sterilizing Autoclave
• IQ Protocol – Sterilizing Autoclave
• OQ Protocol – Sterilizing Autoclave
• PQ Protocol – Sterilizing Autoclave

Deviations Summary

No significant deviations were noted during the validation process. All protocols were executed as per the approved plans, and any minor discrepancies were documented and resolved in accordance with standard operating procedures.

CPP Verification Summary

The key critical parameters verified during the validation included:

• F0 Mapping
• Vacuum Pulses
• Cycle Logs

All parameters met the acceptance criteria outlined in URS Annex 15 and Annex 11.

Conclusion

The validation of the Sterilizing Autoclave for the production of sterile ophthalmics has been successfully completed. All qualifications (DQ, IQ, OQ, PQ) were executed, and the equipment has been found to be compliant with regulatory requirements. The requalification frequency is set for every 12 months.

Attachments Index

• Attachment 1: DQ Protocol Document
• Attachment 2: IQ Protocol Document
• Attachment 3: OQ Protocol Document
• Attachment 4: PQ Protocol Document
• Attachment 5: Cycle Logs

Approvals

Prepared by: ____________________

Reviewed by: ____________________

Approved by: ____________________