Validation Summary Report (VSR)

Summary

This report documents the validation activities performed on the Microencapsulation Reactor/Vessel, utilized for the development and production of microspheres and microcapsules in the R&D/Production area. The validation process adheres to the guidelines set forth in URS Annex 11 and Annex 15.

Scope and Boundaries

The scope of this validation includes the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the Microencapsulation Reactor/Vessel. The boundaries encompass all operational aspects relevant to the equipment’s use in R&D and production processes.

Executed Protocol List

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

Deviations Summary

No significant deviations were recorded during the validation process. All activities were performed in accordance with established protocols and acceptance criteria.

CPP Verification Summary

The key critical parameters (CPPs) verified during validation include:

• Agitation
• Temperature
• Addition Rate
• Time Records

All CPPs were confirmed to be within the specified limits as per the acceptance criteria outlined in the URS.

Conclusion

The Microencapsulation Reactor/Vessel has been successfully validated in accordance with the DQ, IQ, OQ, and PQ protocols. The equipment meets all specified acceptance criteria, ensuring its suitability for use in R&D/Production of microspheres and microcapsules. Requalification is scheduled for every 12 months.

Attachments Index

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

Approvals

This report is approved by:

• ____________________ – Validation Manager
• ____________________ – Quality Assurance Representative
• ____________________ – R&D/Production Lead