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quality assurance

IQ, OQ and PQ: Why Are They Important in the Manufacturing of Cell and Gene Therapies?

Understanding the cell and gene therapy (CGT) development process from start to finish often comes down to learning the language. For individuals more familiar with the early R&D steps in this process, terms like IQ, OQ and PQ – associated with later manufacturing steps – may be completely new. To get us started: IQ stands for installation qualification; OQ is operational qualification; and, PQ is performance qualification. Simply put, these are three steps in a validation process that ensures the equipment used in manufacturing works the way it’s supposed to.

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