Pass Box (Dynamic with HEPA) – Validation Summary Report (VSR) Template

Validation Summary Report

Equipment: Pass Box (Dynamic with HEPA)

Subcategory: Solid Dosage Form (OSD)

Area: Facility

1. Summary

This Validation Summary Report (VSR) provides an overview of the validation activities conducted for the Pass Box (Dynamic with HEPA) used in the Solid Dosage Form (OSD) facility. The validation process includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with the URS, ISO 14644, and Annex 11 guidelines.

2. Scope/Boundaries

The scope of this validation encompasses the installation, operation, and performance of the Pass Box (Dynamic with HEPA) within the OSD facility. The boundaries of the validation include the equipment’s critical parameters, including airflow, HEPA integrity, interlocks, and alarms.

3. Executed Protocol List

  • DQ Protocol: Pass Box (Dynamic with HEPA) – Completed
  • IQ Protocol: Pass Box (Dynamic with HEPA) – Completed
  • OQ Protocol: Pass Box (Dynamic with HEPA) – Completed
  • PQ Protocol: Pass Box (Dynamic with HEPA) – Completed

4. Deviations Summary

No deviations were recorded during the validation process. All protocols were executed as planned, meeting the specified acceptance criteria.

5. CPP Verification Summary

The key critical parameters verified during the validation include:

  • Airflow: Verified to meet specifications.
  • HEPA Integrity: Confirmed through testing.
  • Interlocks: Functionality tested and verified.
  • Alarms: Operational and tested for accuracy.

6. Conclusion

The validation activities for the Pass Box (Dynamic with HEPA) have been successfully completed. All acceptance criteria referenced in the URS, ISO 14644, and Annex 11 have been met. The equipment is qualified for use in the Solid Dosage Form facility.

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7. Requalification Frequency

The Pass Box (Dynamic with HEPA) is scheduled for requalification every 12 months to ensure ongoing compliance and performance.

8. Attachments Index

  • Attachment 1: DQ Protocol Document
  • Attachment 2: IQ Protocol Document
  • Attachment 3: OQ Protocol Document
  • Attachment 4: PQ Protocol Document
  • Attachment 5: Test Results Summary

9. Approvals

Approved by:

  • Validation Manager: ____________________ Date: __________
  • Quality Assurance: ____________________ Date: __________
  • Facility Manager: ____________________ Date: __________

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