Validation Summary Report (VSR)

Equipment: Fluid Bed Granulator (FBG)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Granulation

Summary

This Validation Summary Report outlines the validation activities performed for the Fluid Bed Granulator (FBG) used in the production of solid dosage forms. The validation process includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as per the established protocols and regulatory standards.

Scope/Boundaries

The scope of this validation encompasses the Fluid Bed Granulator utilized in the granulation process within the production area. The report covers all relevant activities from DQ through PQ, ensuring compliance with URS Annex11 acceptance criteria.

Executed Protocol List

• DQ Protocol – Fluid Bed Granulator
• IQ Protocol – Fluid Bed Granulator
• OQ Protocol – Fluid Bed Granulator
• PQ Protocol – Fluid Bed Granulator

Deviations Summary

No deviations were observed during the validation activities. All protocols were executed as per the approved plans, and all acceptance criteria were met.

CPP Verification Summary

Key critical parameters verified during the validation process include:

• Temperature
• Airflow
• Spray Rate
• Filter Differential Pressure (DP)
• Programmable Logic Controller (PLC) performance

All critical parameters were within the specified limits as defined in the URS Annex11.

Conclusion

The Fluid Bed Granulator has been successfully validated for use in solid dosage form production. All DQ, IQ, OQ, and PQ activities have been completed, and the equipment meets the acceptance criteria outlined in URS Annex11. The requalification frequency is established at 24 months.

Attachments Index

• Attachment 1: DQ Protocol Document
• Attachment 2: IQ Protocol Document
• Attachment 3: OQ Protocol Document
• Attachment 4: PQ Protocol Document
• Attachment 5: Validation Summary Data

Approvals

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

• Validation Manager: ____________________
• Quality Assurance: ____________________
• Production Manager: ____________________