Validation Summary Report (VSR)

Summary

This Validation Summary Report provides an overview of the validation activities conducted for the Liquid Manufacturing Vessel (SS Jacketed Tank) used in the production of non-sterile liquids, including oral liquids, syrups, and suspensions.

Scope/Boundaries

The scope of this validation encompasses the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the Liquid Manufacturing Vessel. The boundaries include all relevant functionalities and parameters as outlined in the User Requirement Specification (URS) Annex 11.

Executed Protocol List

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

Deviations Summary

No deviations were reported during the validation process. All activities were executed in accordance with the approved protocols.

CPP Verification Summary

The following key critical parameters were verified during the validation activities:

• Agitation Speed
• Temperature
• Hold Time
• PLC Logs

All parameters were found to be within the acceptance criteria as specified in the URS Annex 11.

Conclusion

The validation of the Liquid Manufacturing Vessel (SS Jacketed Tank) has been successfully completed. The equipment meets all specified requirements and is deemed qualified for use in the production of non-sterile liquids. Requalification is scheduled every 24 months.

Attachments Index

• Attachment 1: DQ Protocol
• Attachment 2: IQ Protocol
• Attachment 3: OQ Protocol
• Attachment 4: PQ Protocol
• Attachment 5: Validation Summary Report

Approvals

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

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