Validation Summary Report

Equipment: Oscillating Granulator

Subcategory: Solid Dosage Form (OSD)

Area: Production/Milling

Summary

This Validation Summary Report (VSR) provides an overview of the validation activities conducted for the Oscillating Granulator used in the production of Solid Dosage Forms. The equipment has undergone Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure compliance with established standards and specifications.

Scope/Boundaries

The scope of this validation includes the assessment of the Oscillating Granulator within the Production/Milling area, focusing on its functionality and performance in the manufacturing process of solid dosage forms. The boundaries encompass all critical parameters and performance metrics as outlined in the User Requirements Specification (URS).

Executed Protocol List

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

Deviations Summary

No deviations were noted during the execution of the qualification protocols. All activities were performed as per the approved protocols and within the defined acceptance criteria.

CPP Verification Summary

The key critical parameters verified include:

Speed
Screen Size
Output Particle Size Distribution (PSD)

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

Conclusion

The Oscillating Granulator has been successfully validated in accordance with regulatory requirements and internal quality standards. It is deemed fit for use in the production of solid dosage forms, with a requalification frequency set at 24 months.

Attachments Index

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

Approvals

This report has been reviewed and approved by the following personnel:

Quality Assurance Manager: [Name]
Validation Manager: [Name]
Production Manager: [Name]