Validation Summary Report (VSR)

Equipment: CIP Skid (Sterile/LVP)

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

Area: Production/Cleaning

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

Acceptance Criteria Reference: URS Annex 11 Annex 15

Key Critical Parameters: Flow, Temperature, Conductivity, Cycle Time, Audit Trail

Requalification Frequency: 12 Months

Summary

This Validation Summary Report outlines the validation activities performed for the CIP Skid used in the production of IV infusions. The report includes details on the execution of the DQ, IQ, OQ, and PQ protocols, as well as a summary of deviations and critical parameter verification.

Scope/Boundaries

The scope of this validation encompasses the CIP Skid utilized for cleaning and sterilization of equipment used in the production of IV infusions. The boundaries of this validation include all relevant operational parameters and systems associated with the CIP process.

Executed Protocol List

DQ Protocol – CIP Skid
IQ Protocol – CIP Skid
OQ Protocol – CIP Skid
PQ Protocol – CIP Skid

Deviations Summary

No deviations were noted during the execution of the validation protocols. All critical parameters were met according to the acceptance criteria outlined in the URS.

CPP Verification Summary

The critical process parameters (CPPs) were verified and found to be within the acceptable limits as specified in the URS. Flow rates, temperature settings, conductivity levels, cycle times, and audit trails were all confirmed to meet the established criteria.

Conclusion

The validation of the CIP Skid (Sterile/LVP) has been successfully completed. All protocols were executed as planned, and the equipment meets all acceptance criteria. The system is deemed suitable for use in the production of IV infusions.

Attachments Index

Attachment 1: DQ Protocol Report
Attachment 2: IQ Protocol Report
Attachment 3: OQ Protocol Report
Attachment 4: PQ Protocol Report

Approvals

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Validation Manager

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Quality Assurance