Validation Summary Report (VSR)

Equipment

Bottle Washing / Rinsing Machine

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

• Rinse Pressure
• Particulate Removal
• PLC Logs

Requalification Frequency

12 Months

Summary

This Validation Summary Report outlines the validation activities conducted for the Bottle Washing / Rinsing Machine utilized in the production of IV Infusions. The report summarizes the executed protocols, deviations encountered, and the verification of critical process parameters.

Scope/Boundaries

The scope of this validation includes the installation, operational, and performance qualifications of the Bottle Washing / Rinsing Machine. The boundaries are defined by the equipment’s operational limits and the critical parameters necessary to ensure effective cleaning and rinsing.

Executed Protocol List

• DQ Protocol
• IQ Protocol
• OQ Protocol
• PQ Protocol

Deviations Summary

No significant deviations were encountered during the validation process. All protocols were executed as planned, and any minor observations were addressed and documented.

CPP Verification Summary

All critical process parameters were verified and met the acceptance criteria outlined in the URS Annex 11. The rinse pressure was consistently within the specified range, and particulate removal was validated through appropriate testing.

Conclusion

The Bottle Washing / Rinsing Machine has successfully met all validation requirements and is deemed suitable for use in the production of IV Infusions. The equipment is compliant with regulatory standards and is ready for routine operation.

Attachments Index

• Executed Protocols
• Deviation Reports
• CPP Verification Data
• Approval Signatures

Approvals

This report has been reviewed and approved by the following personnel:

• Quality Assurance Manager: [Name]
• Validation Manager: [Name]
• Production Manager: [Name]