Qualified Person
Encyclopedia
Qualified Person is a technical term used in European Union
pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use). 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.
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).
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use). 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
EudraLex
EudraLex is the collection of rules and regulations governing medicinal products in the European Union.-Volumes:EudraLex consists of 10 volumes:*Concerning Medicinal Products for Human use:**Volume 1 - Pharmaceutical Legislation....
, Volume 4, Chapter 1) The QP is typically a licensed pharmacist
Pharmacist
Pharmacists are allied health professionals who practice in pharmacy, the field of health sciences focusing on safe and effective medication use...
, biologist
Biologist
A biologist is a scientist devoted to and producing results in biology through the study of life. Typically biologists study organisms and their relationship to their environment. Biologists involved in basic research attempt to discover underlying mechanisms that govern how organisms work...
or chemist
Chemist
A chemist is a scientist trained in the study of chemistry. Chemists study the composition of matter and its properties such as density and acidity. Chemists carefully describe the properties they study in terms of quantities, with detail on the level of molecules and their component atoms...
(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.
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
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme are two international instruments between countries and pharmaceutical inspection authorities...
(PIC/S), the same role may be termed Responsible Person (RP) or Authorized Person (AP).
See also
- EudraLexEudraLexEudraLex is the collection of rules and regulations governing medicinal products in the European Union.-Volumes:EudraLex consists of 10 volumes:*Concerning Medicinal Products for Human use:**Volume 1 - Pharmaceutical Legislation....
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
- EUDRANETEUDRANETEUDRANET, the European Telecommunication Network in Pharmaceuticals , is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and evaluation of applications...
- Ethics CommitteeEthics Committee (European Union)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 non-medical members, whose responsibility it is to protect the rights, safety and well being of human subjects involved in a clinical...
- Clinical trialClinical trialClinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...