Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities performed for the Sterile Filtration Skid used in the production of IV Infusions (LVP/SVP – Bags/Bottles). The report confirms that the equipment has been qualified according to the established protocols and acceptance criteria.

Scope and Boundaries

The scope of this VSR includes the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the Sterile Filtration Skid. The boundaries of this validation encompass the equipment’s use in the production area for the manufacture of sterile IV infusions.

Executed Protocol List

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

Deviations Summary

No deviations were recorded during the qualification process. All activities were performed in accordance with the established protocols and acceptance criteria.

CPP Verification Summary

The key critical parameters verified during the qualification include:

• Flow
• DP (Differential Pressure)
• Integrity
• Integration Audit Trail

All critical parameters met the acceptance criteria as specified in the User Requirement Specification (URS) Annex 1 and Annex 11.

Conclusion

The Sterile Filtration Skid has been successfully validated for use in the production of IV Infusions. It meets all acceptance criteria and is compliant with regulatory requirements. The equipment is approved for routine use with a requalification frequency of 12 months.

Attachments Index

• Attachment 1: DQ Protocol
• Attachment 2: IQ Protocol
• Attachment 3: OQ Protocol
• Attachment 4: PQ Protocol
• Attachment 5: Acceptance Criteria Documentation

Approvals

Prepared by: [Name], [Title], [Date]

Reviewed by: [Name], [Title], [Date]

Approved by: [Name], [Title], [Date]