Validation Summary Report

Equipment: Solution Preparation Tank (Salt/Sugar Dissolution)

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

Area: Production

Summary

This Validation Summary Report provides an overview of the validation activities conducted for the Solution Preparation Tank used in the production of IV infusions. The validation process includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Scope/Boundaries

The scope of this validation encompasses the Solution Preparation Tank utilized for the dissolution of salts and sugars in the production of LVP/SVP IV infusions. The boundaries include the equipment itself and its associated control systems.

Executed Protocol List

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

Deviations Summary

No deviations were recorded during the validation process. All activities were executed as per the established protocols.

CPP Verification Summary

The following key critical parameters were verified during the validation:

• Temperature
• Agitation Time
• Conductivity
• PLC Logs

All parameters met the acceptance criteria as outlined in the URS Annex 11.

Conclusion

The validation activities conducted for the Solution Preparation Tank confirm that the equipment is compliant with the established acceptance criteria. The equipment is suitable for its intended use in the production of IV infusions.

Attachments Index

• Attachment 1: DQ Protocol
• Attachment 2: IQ Protocol
• Attachment 3: OQ Protocol
• Attachment 4: PQ Protocol
• Attachment 5: URS Annex 11

Approvals

This report has been reviewed and approved by:

• Quality Assurance: ____________________
• Production Manager: ____________________
• Validation Manager: ____________________

Requalification Frequency

Requalification is scheduled to occur every 12 months.