Quality Control and Assurance in the Pharmaceutical Industry

3 Credits

The two most important elements of quality assurance in the pharmaceutical industry are good laboratory practices (GLP) and good manufacturing practices (GMP) since they directly address the quality of the drug product. The basis for the understanding of GLP and GMP in the pharmaceutical and related industries will be covered as well as an overview of the accreditation process for several regulatory agencies including the US Food Drug Administration (FDA) and the European Medicines Agency (EMA).