A Qualified Person is a technical term used in EU pharmaceutical regulation. The regulations specify that no batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements. The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. In countries that are part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the same role may be termed Responsible Person (RP) or Authorized Person (AP).
Cheryl Abernathy and Bryan Sasbon, Quality Assurance Operations Manager, Ropack Pharma Solutions; QA Director & Regulatory Affairs, Ropack Pharma Solutions||September 8, 2016 Embracing the process as a means to a strong quality culture