A Qualified Person (QP) is a legally designated individual responsible for certifying that each batch of a medicinal product — including biologics, cell and gene therapies, and viral vectors — has been manufactured, tested, and reviewed in compliance with GMP requirements and applicable regulatory specifications before it is released for clinical or commercial use. The QP role is a mandatory regulatory requirement under EU GMP legislation (Directive 2001/83/EC), and the individual must meet defined educational and professional experience criteria recognized by the competent authority of the relevant EU member state. In a CDMO context, the QP plays a central role in batch release, regulatory compliance, and quality oversight.
