Validation Summary Report

Equipment: Ophthalmic Sterile Filtration Skid (0.22 µm)

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Production

DQ/IQ/OQ/PQ Flags

Design Qualification (DQ): Yes
Installation Qualification (IQ): Yes
Operational Qualification (OQ): Yes
Performance Qualification (PQ): Yes

Acceptance Criteria Reference

URS Annex1 Annex11

Key Critical Parameters

Flow
DP Integrity
Integration Audit Trail

Requalification Frequency

12 Months

Summary

This Validation Summary Report outlines the validation activities performed for the Ophthalmic Sterile Filtration Skid, ensuring compliance with applicable regulations and standards.

Scope/Boundaries

The scope of this validation encompasses the installation, operational, and performance qualifications of the sterilization process for ophthalmic products.

Executed Protocol List

Protocol DQ-001: Design Qualification
Protocol IQ-001: Installation Qualification
Protocol OQ-001: Operational Qualification
Protocol PQ-001: Performance Qualification

Deviations Summary

No deviations were noted during the execution of the validation protocols.

CPP Verification Summary

All critical process parameters have been verified and meet the established acceptance criteria.

Conclusion

The validation activities for the Ophthalmic Sterile Filtration Skid have been successfully completed, demonstrating that the equipment operates within the specified parameters and meets regulatory requirements.

Attachments Index

Attachment A: DQ Protocol
Attachment B: IQ Protocol
Attachment C: OQ Protocol
Attachment D: PQ Protocol
Attachment E: Validation Summary Report

Approvals

Prepared by: ____________________

Reviewed by: ____________________

Approved by: ____________________