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Encyclopedia > Good Distribution Practice

Good Distribution Practice or GDP deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs, intended for human consumption. Distribution is one of the four aspects of marketing. ...


GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.


In the USA the Food and Drug Administration wants to deal with the growing public health problem of counterfeit prescription drugs. Counterfeit drugs are not only illegal but are also inherently unsafe. In the near future the FDA will require that the pharmaceutical industry implements full-scale RFID serialization (needed for closed-loop drug tracking) and electronic pedigree (ePedigree) applications (needed to find and prosecute violators). The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food (humans and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal) and radiation emitting devices (including non-medical devices), biologics, and... The examples and perspective in this article or section may not represent a worldwide view. ... An EPC RFID tag used for Wal-Mart Radio Frequency Identification (RFID) is an automatic identification method, relying on storing and remotely retrieving data using devices called RFID tags or transponders. ...


Legislation

In Europe GDP is based on the Directive of the Board of the European Community 92/25/EEC regarding the wholesale distribution of drugs for human consumption. European redirects here. ... The European Community (EC), most important of two European Communities, was originally founded on March 25, 1957 by the signing of the Treaty of Rome under the name of European Economic Community. ...


See also

The term GxP is a generalization of quality guidelines, predominantly used in the pharmaceutical industry. ... Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drugs (known as medicinal products in Europe), medical devices, diagnostic products, foods products and Active Pharmaceutical Ingredients (APIs). ... The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. ... The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. ... The Ministry of Health of Japan is a part of the Japanese government that has a responsibility to provide health care regulations in Japan. ...

External links

  • Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
  • Counterfeit Drugs (FDA)
  • Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (FDA)

 
 

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