Regulations and Standards

European Union In the European Union, the inspection of both sub-visible and visible particles in parenteral products is governed by the European Medicines Agency (EMA) and the European Pharmacopoeia, with detailed guidelines ensuring the safety and quality of injectable medications. Here’s a comprehensive overview of the regulations: Visible Particles Sub-visible Particles Japan In Japan, the […]

Regulation and Guideline of particles inspection in parenteral products in USA In the United States, the regulation of sub-visible and visible particle inspection in parenteral products is primarily governed by the Food and Drug Administration (FDA) and outlined in the United States Pharmacopeia (USP). These regulations ensure the safety and quality of injectable medications through

United States European Union International Standards Specific Considerations for Dialysis Catheters Post-Market Surveillance National Regulations