Validation Summary Report (VSR)

Equipment Information

Equipment: AHU for Aseptic Area

Subcategory: Sterile (Injectables/Aseptic)

Area: Engineering

DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes

Acceptance Criteria Reference: URS Annex1 Annex11 Annex15

Key Critical Parameters: ACH, airflow, temperature, relative humidity (RH), differential pressure (DP), alarms, trends, audit trail

Requalification Frequency: 6M-12M

Summary

This Validation Summary Report presents the validation activities performed for the AHU designated for the Aseptic Area within the Engineering department. The validation process ensures compliance with applicable regulatory requirements and internal standards.

Scope/Boundaries

The scope of this validation includes the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the AHU system. The boundaries of this report encompass the entire lifecycle of the equipment from installation through performance verification.

Executed Protocol List

• DQ Protocol: [Insert Document Reference]
• IQ Protocol: [Insert Document Reference]
• OQ Protocol: [Insert Document Reference]
• PQ Protocol: [Insert Document Reference]

Deviations Summary

During the validation activities, the following deviations were noted:

• Deviation 1: [Insert Description]
• Deviation 2: [Insert Description]
• Deviation 3: [Insert Description]

CPP Verification Summary

Critical Process Parameters (CPP) were verified during the validation activities:

• ACH: [Insert Results]
• Airflow: [Insert Results]
• Temperature: [Insert Results]
• Relative Humidity: [Insert Results]
• Differential Pressure: [Insert Results]
• Alarms: [Insert Results]
• Trends: [Insert Results]
• Audit Trail: [Insert Results]

Conclusion

The validation of the AHU for the Aseptic Area has been successfully completed in accordance with the established protocols and acceptance criteria. All critical parameters were verified and no unresolved deviations remain. The equipment is deemed qualified for its intended use.

Attachments Index

• Attachment 1: [Insert Document Reference]
• Attachment 2: [Insert Document Reference]
• Attachment 3: [Insert Document Reference]

Approvals

Prepared by: [Insert Name and Title]

Reviewed by: [Insert Name and Title]

Approved by: [Insert Name and Title]