Validation Summary Report (VSR)

Equipment Information

Equipment: Water System (PW/WFI) – Point of Use for LVP

Subcategory: IV Infusions (LVP/SVP – Bags/Bottles)

Area: Utilities

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

Acceptance Criteria Reference: URS Annex11 Annex15

Key Critical Parameters: Conductivity, TOC, Microbial, Temperature, Audit Trail

Requalification Frequency: 12 Months

Summary

This Validation Summary Report details the validation activities conducted for the Water System (PW/WFI) – Point of Use for LVP. The report summarizes the execution of the DQ, IQ, OQ, and PQ phases and evaluates the system’s compliance with the established acceptance criteria.

Scope and Boundaries

The scope of this validation encompasses the Water System (PW/WFI) utilized for the preparation of LVP. The boundaries include all operational and monitoring parameters as defined in the validation protocols.

Executed Protocol List

DQ Protocol – Water System (PW/WFI)
IQ Protocol – Water System (PW/WFI)
OQ Protocol – Water System (PW/WFI)
PQ Protocol – Water System (PW/WFI)

Deviations Summary

No deviations were noted during the execution of the validation protocols. All activities were performed as per the approved protocols.

CPP Verification Summary

All critical parameters were verified and met the acceptance criteria as defined in the URS. The following parameters were assessed:

Conductivity: Compliant
TOC: Compliant
Microbial: Compliant
Temperature: Compliant
Audit Trail: Compliant

Conclusion

The validation of the Water System (PW/WFI) – Point of Use for LVP has been successfully completed. The system operates within defined specifications and complies with regulatory requirements. The system is deemed suitable for its intended use.

Attachments Index

Attachment 1: DQ Protocol
Attachment 2: IQ Protocol
Attachment 3: OQ Protocol
Attachment 4: PQ Protocol
Attachment 5: Validation Plan

Approvals

Prepared by: [Name, Title, Date]

Reviewed by: [Name, Title, Date]

Approved by: [Name, Title, Date]