Validation Summary Report

Equipment: Inline Conductivity Meter

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

Area: Production

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

Acceptance Criteria Reference: URS Annex 11

Key Critical Parameters: Accuracy, Alarms, Audit Trail

Requalification Frequency: 12 Months

Summary

This Validation Summary Report provides an overview of the validation activities performed for the Inline Conductivity Meter utilized in the production area for IV infusions. The report outlines the execution of the validation protocols and the results obtained, ensuring compliance with regulatory requirements.

Scope/Boundaries

The scope of this validation encompasses the installation, operational, and performance qualifications of the Inline Conductivity Meter. It includes all relevant documentation and activities related to its use in the production of IV infusions.

Executed Protocol List

DQ Protocol – Inline Conductivity Meter
IQ Protocol – Inline Conductivity Meter
OQ Protocol – Inline Conductivity Meter
PQ Protocol – Inline Conductivity Meter

Deviations Summary

During the validation process, no deviations from the protocols were observed. All tests were executed as per the approved protocols, and results were within the specified acceptance criteria.

CPP Verification Summary

The critical process parameters (CPPs) related to accuracy, alarms, and audit trails were verified during the OQ and PQ phases. All parameters met the acceptance criteria as outlined in the URS Annex 11.

Conclusion

The Inline Conductivity Meter has been successfully validated in accordance with regulatory requirements and internal quality standards. It is deemed suitable for use in the production of IV infusions, with a requalification frequency established 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: Validation Summary Report

Approvals

Prepared by: ____________________

Title: ____________________

Date: ____________________

Reviewed by: ____________________