Validation Summary Report (VSR)

Equipment: Bottle Blow Molding Machine

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

Area: Production

DQ/IQ/OQ/PQ Flags

Design Qualification (DQ): Yes
Installation Qualification (IQ): Yes
Operational Qualification (OQ): Yes
Performance Qualification (PQ): Yes

Acceptance Criteria Reference

URS Annex11

Key Critical Parameters

Temperature
Cycle Time
Dimensional Control
Alarms

Requalification Frequency

24 Months

Summary

This Validation Summary Report provides an overview of the validation activities performed for the Bottle Blow Molding Machine used in the production of IV Infusions. The report outlines the execution of the DQ, IQ, OQ, and PQ phases, ensuring compliance with regulatory requirements and internal standards.

Scope and Boundaries

The scope of this validation encompasses the Bottle Blow Molding Machine’s performance in producing IV infusion bags and bottles, including all critical parameters and operational conditions as specified in the URS Annex11.

Executed Protocol List

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

Deviations Summary

All deviations encountered during the validation process were documented and assessed. No critical deviations impacted the validation outcome.

CPP Verification Summary

Critical Process Parameters (CPP) were verified against acceptance criteria. All parameters met the specified limits, ensuring the machine operates within validated conditions.

Conclusion

The validation activities for the Bottle Blow Molding Machine have been successfully completed. All qualification phases were executed in accordance with the established protocols, and the machine is deemed qualified for use in the production of IV infusion products.

Attachments Index

Attachment 1: DQ Protocol
Attachment 2: IQ Protocol
Attachment 3: OQ Protocol
Attachment 4: PQ Protocol
Attachment 5: Deviations Log
Attachment 6: CPP Verification Report

Approvals

Report Prepared By: ___________________ Date: ___________

Approved By: __________________________ Date: ___________