Equipments qualifications
The Qualification Process: IQ/OQ/PQ/ and PV
IQ, OQ, and PQ are sequential activities that have to be carried out to validate the manufacturing and QC processes. IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely. It is also to demonstrate that the manufacturing process under normal operating conditions will consistently produce conforming products.
Cyclotron and synthesis system manufacturers and a few quality control equipment manufacturers typically perform IQ and OQ as a part of system installation.
As the I initial qualification is mandatory and very important, we highly recommend annual re-qualification for your cyclotron facility and equipments which we offer for our clients.
