What are a “Qualified Person” (QP) and a “Responsible Person” (RP)? How do their roles in pharmaceutical regulation differ?

A “Qualified Person” (QP) and a “Responsible Person” (RP) are two distinct but equally important roles in the regulatory framework for medicines. QP is a legal concept under the EU and PIC/S GMP systems and is primarily found in pharmaceutical manufacturing. The QP’s core responsibility is to personally review batch records and issue a declaration before each batch of medicine is placed on the market, confirming that the manufacturing and testing of the batch fully comply with GMP requirements and the marketing authorisation. The QP bears personal legal responsibility for product quality. By contrast, the RP is a GDP concept found primarily in pharmaceutical wholesale and distribution. The RP is responsible for ensuring that the wholesaler’s Quality Management System is effectively implemented and maintained, and that medicines retain their quality and integrity during storage and distribution. The RP is responsible for compliance in wholesale activities. In short, the QP is responsible for “release from manufacture” and ensuring manufacturing quality; the RP is responsible for “distribution compliance” and ensuring supply chain quality.