Ophthalmic Bottle Washing Machine – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Equipment: Ophthalmic Bottle Washing Machine

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Production

Summary

This Validation Summary Report provides an overview of the validation activities conducted for the Ophthalmic Bottle Washing Machine, ensuring compliance with regulatory requirements and internal standards.

Scope/Boundaries

The scope of this validation includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the Ophthalmic Bottle Washing Machine. The boundaries of this validation encompass all operational parameters relevant to the production of sterile eye drops and eye ointments.

Executed Protocol List

  • DQ Protocol – Reference No: DQ-OBWM-001
  • IQ Protocol – Reference No: IQ-OBWM-001
  • OQ Protocol – Reference No: OQ-OBWM-001
  • PQ Protocol – Reference No: PQ-OBWM-001

Deviations Summary

No deviations were observed during the execution of the validation protocols. All activities were performed in accordance with the established procedures.

CPP Verification Summary

The following Key Critical Parameters (CPPs) were verified:

  • Wash Pressure: Complied with acceptance criteria.
  • Temperature: Complied with acceptance criteria.
  • Particulate Removal: Complied with acceptance criteria.
  • PLC Logs: Reviewed and validated.

Conclusion

The validation activities for the Ophthalmic Bottle Washing Machine have been successfully completed, demonstrating that the equipment meets the specified requirements and is suitable for use in the production of sterile ophthalmic products.

Attachments Index

  • Attachment 1: DQ Protocol Report
  • Attachment 2: IQ Protocol Report
  • Attachment 3: OQ Protocol Report
  • Attachment 4: PQ Protocol Report
  • Attachment 5: Validation Summary Report

Approvals

Prepared by: ____________________ Date: ___________

See also  Plunger Insertion Machine – Traceability Matrix (URS ↔ Tests)

Reviewed by: ____________________ Date: ___________

Approved by: ____________________ Date: ___________

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