Jet Mill / Spiral Mill – Validation Summary Report (VSR) Template

Validation Summary Report

Equipment: Jet Mill / Spiral Mill

Subcategory: NDDS – Inhaled NDDS Powders (Engineered Particles)

Area: R&D/Production

DQ/IQ/OQ/PQ Flags

Design Qualification: Yes

Installation Qualification: Yes

Operational Qualification: Yes

Performance Qualification: Yes

Acceptance Criteria Reference

URS Annex 11 Annex 15

Key Critical Parameters

  • Pressure
  • Feed Rate
  • PSD Control
  • Containment

Requalification Frequency

12 Months

Summary

This Validation Summary Report outlines the validation activities performed for the Jet Mill / Spiral Mill used in the production of inhaled NDDS powders. The report confirms that the equipment meets the defined acceptance criteria and is compliant with relevant regulatory standards.

Scope/Boundaries

The scope of this validation encompasses the installation, operation, and performance qualifications of the Jet Mill / Spiral Mill within the R&D/Production area. The boundaries include all processes related to the production of inhaled NDDS powders.

Executed Protocol List

  • Design Qualification Protocol (DQP)
  • Installation Qualification Protocol (IQP)
  • Operational Qualification Protocol (OQP)
  • Performance Qualification Protocol (PQP)

Deviations Summary

No deviations were recorded during the validation process. All activities were executed as per the approved protocols.

CPP Verification Summary

All critical process parameters (CPPs) were verified and found to be within the established acceptance criteria. The parameters monitored include pressure, feed rate, PSD control, and containment.

Conclusion

The validation of the Jet Mill / Spiral Mill for inhaled NDDS powders has been successfully completed. The equipment is deemed qualified for its intended use, and it complies with the acceptance criteria outlined in the URS Annex 11 Annex 15.

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Attachments Index

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

Approvals

__________________________
Validation Manager
Date: ____________

__________________________
Quality Assurance Representative
Date: ____________

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