Qualification Certificate

Equipment Information

Equipment: Extrusion Machine

Subcategory: Implants (Drug-Eluting / Biodegradable)

Area: Production

Equipment Identifier: [Equipment Identifier]

Qualification Summary

DQ/IQ/OQ/PQ Flags: Yes / Yes / Yes / Yes

Requalification Frequency: 12 Months

Protocol References: [Protocol Reference]

Execution Dates: [Execution Dates]

Calibration Status: [Calibration Status]

Deviations Summary: [Deviations Summary]

Overall Qualification Statement

The Extrusion Machine has been successfully qualified in accordance with established protocols and meets all operational requirements for the production of Drug-Eluting and Biodegradable Implants.

Approvals

Qualified By: [Qualified By]

Approved By: [Approved By]

Next Due Date

Next Due Date: [Next Due Date]