Risk-based Management of GMP Audits

Within the European Union the manufacturing of medicinal products has undoubtedly reached a very high quality level. The principles of Good Manufacturing Practice (GMP) are required by law. A relevant part of the quality of finished products depends on the quality of the starting material, especially of the active pharmaceutical ingredients (APIs). In the framework of globalisation and due to the ever-increasing cost pressure APIs are meanwhile sourced in a worldwide market, mainly in Asia. The risk of sourcing substandard, contaminated or adul ...