Verunreinigungen in generischen Arzneimitteln
Dr. Christian Zeine
LGC Standards GmbH, Wesel
Impurities in Generic Drug Products
In November 2010, the FDA published the Guidance for Industry “ANDAs: Impurities in Drug Products” and made official their view on how to deal with impurities in generic drug products. Together with their guidance for impurities in generic drug substances published already in June 2009, the FDA’s picture is now complete.
Both documents mirror the view of FDA that for generics the prinicples of ICH guidelines Q3A and Q3B do apply, which were designed originally for new drug substances/products.
So the FDA is now in accordance with the European point of view. There for some time, with the EU Guideline 2001/83/EU, the texts in the European Pharmacopeia and the EMA Guideline CPMP/QWP/1529/04 of 2004, regulation is already going in that direction. Also in the Japanese market the relevance of Q3A and Q3B for generic products is recognized. For these, product specifications for impurities are closely monitored.
The following article discusses the FDA Guidances and shows how clever analytical work can avoid extensive qualification studies. Also, it will point out the risk of hidden costs resulting from work with insufficiently characterised impurity reference standards.