Validation Summary Report (VSR)

Equipment

Extrusion Machine

Subcategory

Implants (Drug-Eluting / Biodegradable)

Area

Production

DQ/IQ/OQ/PQ Flags

Yes / Yes / Yes / Yes

Acceptance Criteria Reference

URS Annex 11

Key Critical Parameters

• Extrusion Temperature
• Pressure
• Speed
• Audit Trail Logs

Requalification Frequency

12 Months

Summary

This report summarizes the validation activities performed on the Extrusion Machine used for the production of drug-eluting and biodegradable implants. The validation process adhered to the established protocols and acceptance criteria as outlined in URS Annex 11.

Scope/Boundaries

The validation encompasses the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of the Extrusion Machine. The scope includes the evaluation of critical parameters and system functionalities within the production area.

Executed Protocol List

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

Deviations Summary

No significant deviations were noted during the validation process. All activities were conducted in accordance with the approved protocols.

CPP Verification Summary

All critical process parameters (CPP) were verified and found to be within the acceptance criteria. The parameters monitored include extrusion temperature, pressure, speed, and audit trail logs.

Conclusion

The validation of the Extrusion Machine has been successfully completed. The equipment is qualified for use in the production of drug-eluting and biodegradable implants in compliance with regulatory requirements.

Attachments Index

• Executed Protocols
• Validation Data
• Calibration Certificates
• Deviation Reports

Approvals

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Validation Manager

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Quality Assurance