Qualifications

IQ/OQ/PQ/ and PV

Installation Qualification, Operational Qualification, and Performance Qualification are parts of verification procedures used together for checking that equipment meets requirements and specifications and that it fulfills its intended purpose

Cyclomedical has qualified equipment and procedures for more than 40 international PET production laboratories, performing IQ, OQ, PQ, PV and staff training.  All of our clients have passed regulatory agency or third party validation of equipment or process.

Cyclotron and synthesis system manufacturers and a few quality control equipment manufacturers typically perform IQ and OQ as a part of system installation.  These tests verify that the equipment is correctly installed and that it meets manufacturer’s specifications. 

The selected equipment must have fulfilled the Design Qualification (DQ) specifications for that purpose.  Process Verification (PV) is verification that the product or system will meet specifications. 

PQ, where the intended purpose is performance of procedures described in product monographs in an internationally accepted Pharmacopeia (e.g., US, Eu), is a suitability test of the equipment for that procedure (examples are [18F]FDG, [13N]Ammonia, [18F]NaF).  This qualification is generally repeated annually.

For procedures not found in a Pharmacopeia, PQ will include Analytical Validation of the procedures which is much more complex.  Release tests for research products are examples of procedures requiring analytical validation.

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