Validation Summary Report (VSR)

Summary

This Validation Summary Report documents the validation activities for the Sterile Holding Tank (Pressurized) utilized in the production of sterile powders and lyophilized products. The report confirms compliance with relevant regulatory standards and internal requirements.

Scope and Boundaries

The scope of this validation encompasses the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the Sterile Holding Tank. The boundaries include all related processes, equipment, and documentation necessary to ensure the integrity and reliability of the sterile holding system.

Executed Protocol List

• DQ Protocol – Sterile Holding Tank
• IQ Protocol – Sterile Holding Tank
• OQ Protocol – Sterile Holding Tank
• PQ Protocol – Sterile Holding Tank

Deviations Summary

No deviations were noted during the execution of the qualification protocols. All activities were performed in accordance with the established procedures and acceptance criteria.

CPP Verification Summary

The key critical parameters verified during the qualification include:

• Pressure hold integrity
• Vent integrity
• PLC logs review

All parameters were found to be within the acceptance criteria as outlined in URS Annex1 Annex15.

Conclusion

The validation activities for the Sterile Holding Tank (Pressurized) have been successfully completed, demonstrating that the equipment meets the required specifications and is capable of performing its intended function. The requalification frequency is set at 12 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: Pressure Hold Test Results
• Attachment 6: PLC Log Summary

Approvals

Prepared by: [Name, Title]

Reviewed by: [Name, Title]

Approved by: [Name, Title]