Qualified Person (QP) is a technical term used in European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use). The European Union ( EU) is a political and economic union of twenty-seven member states, located primarily in 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. (EudraLex, Volume 4, Chapter 1) 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. EudraLex is the collection of rules and regulations governing medicinal products in the European Union. Pharmacists are Health professionals who practice the art and science of Pharmacy. The requirement for QP oversight has been extended to material for use in clinical trials since the introduction of EU Directive 2001/20/EC.
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). The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S are two international instruments between countries and pharmaceutical inspection authorities
In Construction practice in the United States, a "qualified person" is someone who, by possession of a recognized degree, certificate, or professional standing, or who by extensive knowledge, training, and experience, has successfully demonstrated his ability to solve or resolve problems relating to the subject matter, the work, or the project.
See also
EudraLex is the collection of rules and regulations governing medicinal products in the European Union. The European Medicines Agency ( EMEA) is a European agency for the evaluation of medicinal products. EUDRANET, the European Telecommunication Network in Pharmaceuticals ( E uropean U nion D rug R egulating A uthorities Net The Ethics Committee, according to Directive 2001/20/EC, is an independent body in a Member State of the European Union, consisting of healthcare professionals and In health care clinical trials are conducted to allow safety and Efficacy data to be collected for new drugs or devicesDapyx Software network: MP3 Explorer | Ebook Manager | Zenithic