GMP Qualification of equipment and facilities

At IDI, we provide a full-service qualification solution that covers every stage from documentation planning to test execution and the issuance of final reports always optimized according to the specific requirements of each client.

 EQUIPMENT AND FACILITIES WE QUALIFY

• Clean Utilities (CIP, SIP, Purified Water, WFI, Pure Steam...).

• Black Utilities (chilled water, compressed air, nitrogen...).

• HVAC Systems and Cleanrooms.

• Laboratory and Production Equipment

• Filling Machines.

WHAT DOES OUR SERVICE INCLUDE?

• PMQP - Project Master Qualification Plan.

• URS - User Requirements Specifications

• SIA - System Impact Assessment.

• Functional Specification.

• FRA - Functional Risk Assessment.

• FAT - Factory Acceptance Test.

• DQ - Design Qualifications.

• VP - Validation Plan.

• QP - Qualification Plan.

• SRA - Sensor Risk Assessment.

• IQ - Installation Qualification.

• SAT - Site Acceptance Test.

• OQ - Operation Qualification.

• PQ - Performance Qualification.

• TM - Traceability Matrix.

• QR - Qualification Report.

• Periodic Reviews.

• Decommissioning.