Validation Summary Report (VSR)

Summary

This Validation Summary Report provides an overview of the qualification activities performed for the Grade A/B/C/D Cleanrooms, focusing on sterile environments for injectables and aseptic processes. The report outlines the execution of the validation protocols and the assessment of critical parameters.

Scope and Boundaries

The scope of this validation encompasses the qualification of Grade A/B/C/D Cleanrooms within the facility, as per the requirements outlined in the User Requirement Specification (URS), ISO 14644, Annex 1, and Annex 15. The boundaries include all areas related to sterile manufacturing processes.

Executed Protocol List

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

Deviations Summary

No deviations were noted during the execution of the qualification protocols. All processes adhered to the established acceptance criteria.

CPP Verification Summary

The following critical parameters were verified during the qualification process:

• ISO Class Recovery
• Air Changes per Hour (ACH)
• Delta Pressure (DP)
• Temperature
• Relative Humidity (RH)
• Airflow Visualization (Smoke Testing)

Conclusion

Based on the executed protocols and the verification of critical parameters, the Grade A/B/C/D Cleanrooms have been successfully qualified in accordance with the specified standards. Requalification is recommended every 6 to 12 months to ensure continued compliance and operational integrity.

Attachments Index

• Attachment 1: User Requirement Specification (URS)
• Attachment 2: Qualification Protocols
• Attachment 3: Raw Data and Results
• Attachment 4: Smoke Test Reports

Approvals

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

• Quality Assurance Manager: ____________________
• Engineering Manager: ____________________
• Validation Lead: ____________________