Air Shower – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Equipment: Air Shower

Subcategory: Solid Dosage Form (OSD)

Area: Facility

Summary

This Validation Summary Report provides an overview of the validation activities undertaken for the Air Shower used in the Solid Dosage Form (OSD) facility. The report includes details on the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, as well as a summary of key critical parameters and requalification frequency.

Scope/Boundaries

The scope of this validation encompasses the Air Shower system used in the OSD facility, focusing on the validation of the equipment’s functionality, performance, and compliance with established acceptance criteria. The boundaries include all operational aspects of the Air Shower, including its integration with other systems within the facility.

Executed Protocol List

  • Design Qualification (DQ) Protocol
  • Installation Qualification (IQ) Protocol
  • Operational Qualification (OQ) Protocol
  • Performance Qualification (PQ) Protocol

Deviations Summary

During the validation process, no deviations from the established protocols were noted. All activities were performed as per the approved protocols, ensuring compliance with the User Requirement Specification (URS).

CPP Verification Summary

The key critical parameters verified during the validation include:

  • Air Velocity
  • Cycle Time
  • Interlocks

All critical parameters met the acceptance criteria as defined in the URS.

Conclusion

The Air Shower system has been successfully validated in accordance with the DQ, IQ, OQ, and PQ protocols. The equipment operates within the specified parameters, and all acceptance criteria have been met. The requalification frequency is established at 24 months.

See also  Barcode Scanner (GMP) – Deviation Impact Assessment

Attachments Index

  • Attachment 1: Design Qualification Report
  • Attachment 2: Installation Qualification Report
  • Attachment 3: Operational Qualification Report
  • Attachment 4: Performance Qualification Report

Approvals

This Validation Summary Report has been reviewed and approved by the following personnel:

  • Validation Manager: ____________________ Date: ___________
  • Quality Assurance: ______________________ Date: ___________
  • Operations Manager: ____________________ Date: ___________

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