Validation Summary Report

Equipment

Particle Size Classification System (Sieves/Air classifier)

Subcategory

NDDS – Microspheres & Microcapsules

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

Key Critical Parameters

Sieve integrity cut size

Requalification Frequency

24 Months

Summary

This Validation Summary Report outlines the validation activities performed for the Particle Size Classification System used in the production of NDDS – microspheres and microcapsules. The report includes the executed protocols, deviations, critical parameter verifications, and approvals.

Scope/Boundaries

The scope of this validation includes the installation, operational, and performance qualifications of the Particle Size Classification System. The boundaries are defined by the equipment’s operational limits and the parameters specified in the User Requirements Specification (URS).

Executed Protocol List

• DQ Protocol
• IQ Protocol
• OQ Protocol
• PQ Protocol

Deviations Summary

No significant deviations were reported during the validation process. All activities were conducted in accordance with the approved protocols.

CPP Verification Summary

All critical process parameters (CPP) were verified and found to be within the acceptance criteria as specified in the URS. The sieve integrity cut size was confirmed to meet the required specifications.

Conclusion

The Particle Size Classification System has been successfully validated in accordance with the established protocols. It is deemed suitable for its intended use in the production of NDDS – microspheres and microcapsules.

Attachments Index

• Executed DQ Protocol
• Executed IQ Protocol
• Executed OQ Protocol
• Executed PQ Protocol
• Deviations Log
• CPP Verification Report

Approvals

Prepared by: [Name]

Approved by: [Name]

Date: [Date]