Experiences in the Inspecting of Quality Systems—An Inspector’s View

Quality Assurance (QA) systems are the statutory norm for phar­ maceutical entrepreneurs in Europe. The individual inputs are either m ade binding by the E uropean Economic Com m unity (EEC) regulations or they were translated into national standards in the European Union (EU) M ember States in accordance with the corresponding EEC Directives (Figure 2.1).