Validation Summary Report (VSR)

Equipment: Bin Dryer (IBC Dryer)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Drying

Summary

This Validation Summary Report outlines the validation activities for the Bin Dryer (IBC Dryer) utilized in the Solid Dosage Form production area. The report details the execution of the DQ, IQ, OQ, and PQ protocols, ensuring compliance with the acceptance criteria established in the URS Annex11.

Scope/Boundaries

The scope of this validation includes the assessment of the Bin Dryer (IBC Dryer) within the production/drying area. The validation encompasses Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases.

Executed Protocol List

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

Deviations Summary

No significant deviations were noted during the validation process. All protocols were executed as per the approved plans.

CPP Verification Summary

The key critical parameters verified during validation include:

Airflow
Temperature
Time
PLC functionality

All critical parameters met the acceptance criteria as specified in URS Annex11.

Conclusion

The validation of the Bin Dryer (IBC Dryer) has been successfully completed, and it is deemed qualified for use in the Solid Dosage Form production area. The equipment will be requalified every 24 months to ensure continued compliance and performance.

Attachments Index

Attachment 1: DQ Protocol Report
Attachment 2: IQ Protocol Report
Attachment 3: OQ Protocol Report
Attachment 4: PQ Protocol Report

Approvals

Prepared by: ______________________

Reviewed by: ______________________

Approved by: ______________________