Validation Summary Report (VSR)

Equipment: Crimping Machine (Pump Fixing)

Subcategory: Nasal & Otic Products (Sterile / Non-Sterile)

Area: Production

Summary

This Validation Summary Report outlines the validation activities performed on the Crimping Machine used for the production of Nasal and Otic products. The validation process includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with the acceptance criteria defined in the URS Annex11.

Scope/Boundaries

The scope of this validation encompasses the Crimping Machine utilized in the production area. It includes the verification of all critical parameters and operational functions necessary for compliance with regulatory standards.

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 encountered during the validation process. All protocols were executed as per the predefined criteria.

CPP Verification Summary

The key critical parameters verified include the crimp force torque audit trail logs. All parameters were found to be within acceptable limits as per the defined acceptance criteria.

Conclusion

The validation of the Crimping Machine (Pump Fixing) has been successfully completed. All qualification activities have met the acceptance criteria outlined in the URS Annex11, and the equipment is deemed suitable for use in the production of Nasal and Otic products.

Attachments Index

Attachment 1: DQ Protocol
Attachment 2: IQ Protocol
Attachment 3: OQ Protocol
Attachment 4: PQ Protocol
Attachment 5: Audit Trail Logs

Approvals

Prepared by: ____________________ Date: ___________

Reviewed by: ____________________ Date: ___________

Approved by: ____________________ Date: ___________