ABSTRACT
When applying medicinal products, the quality, the efficacy and the safety have to be considered with respect of drug laws. According to the German Drug Law (AMG, 1998), the quality of remedies is defined as “the property of a medicinal product being determined according to identity, content, purity, other chemical, physical, biological properties or by the manufacturing procedure”. The manufacturer is obliged by law to take the appropriate measures for the control of quality, constant efficacy and safety of the drug (EU-GMP-Guideline, 1989).
