Frithjof Holtz, advocacy & surveillance life science regulatory management at Merck KGaA offers a practical view on the implementation of the EU Excipient Risk Assessment Guidelines.
Maze
They are often inconspicuous, but just as often indispensable: excipients are far more than passive additions to active pharmaceutical ingredients (APIs). Their critical role in drug production has become the focus of many debates – and of regulatory authorities who are demanding more stringent quality management in excipient production and use.
Whether speaking of anti-adherents or binders, a high quality of the more than one thousand different excipients is essential for drug and patient safety. Regulatory authorities are increasingly demanding stricter quality management in excipient production and use, which affects both excipient suppliers and pharmaceutical manufacturers. Since March 2016, excipient users in the EU are legally mandated to implement GMP requirements of the EU Excipient Risk Assessment Guidelines.