New FDA NDSRI Guidelines
The Food and Drug Administration (FDA) is updating its guidance regarding Nitrosamine Drug Substance-Related Impurities (NDSRIs). With this update, the FDA acknowledges the leading scientific research by introducing a novel framework for determining the Acceptable...
New ECHA Chemicals Enforcement Project
The European Chemical Agency (ECHA) is launching a project to check the compliance of products sold online with REACH and CLP requirements. Currently, chemical products sold online are largely non-compliant. Starting in 2025, ECHA inspectors will check products sold...
Particulate Contamination
Particulate contamination is a risk in pharmaceutical production facilities. Good Manufacturing Practice (GMP) and proper risk management requires identifying root causes and evaluating what impact a particulate matter finding has on product safety. Understanding the...
Nitrosamine Contamination
As a pharmaceutical manufacturer, you need to know whether your products contain nitrosamine impurities and, if so, whether they are below the thresholds established by various regulatory agencies. Nitrosamine impurities can be introduced at any stage in the supply...