Filter Housing (Sterile Grade) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities conducted for the Filter Housing (Sterile Grade) utilized in the production of Ophthalmics, specifically Sterile Eye Drops and Eye Ointments. The report details the execution of the DQ, IQ, OQ, and PQ protocols in accordance with URS Annex 1 acceptance criteria.

Scope/Boundaries

The scope of this validation encompasses the installation, operational, and performance qualifications of the Filter Housing within the production area for sterile ophthalmic products. The boundaries include all associated equipment and systems that interact with the Filter Housing.

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 per the established procedures and acceptance criteria.

CPP Verification Summary

The key critical parameter verified during the validation was the pressure hold seal integrity. All tests met the acceptance criteria as outlined in the URS Annex 1.

Conclusion

The validation activities for the Filter Housing (Sterile Grade) have been successfully completed. The equipment has been demonstrated to meet all specified requirements and is deemed suitable for use in the production of sterile ophthalmic products.

Attachments Index

  • Attachment 1: DQ Protocol and Report
  • Attachment 2: IQ Protocol and Report
  • Attachment 3: OQ Protocol and Report
  • Attachment 4: PQ Protocol and Report

Approvals

Prepared by: ____________________ Date: ____________

Reviewed by: ____________________ Date: ____________

Approved by: ____________________ Date: ____________

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