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.
Health Canada and FDA guidance documents will frequently refer to IQ, OQ and PQ where requirements for equipment are outlined. Understanding IQ, OQ and PQ will set you up for success in transferring your process to a good manufacturing practices (GMP) facility. Developers that are savvy about validation will be able to create appropriate timelines, source the right professionals to do the job, and prepare the necessary documentation well in advance.
In fact, the validation process begins with the developer/client. The quality assurance and operations professional who carries out your validation will ask for a User Requirement Specification document (URS) that outlines exactly what you need your equipment to do. Once they have this information, the validation process can begin.