Challenges and Advantages of International Regulatory Inspections, by Dan Barreto, VP, Compliance

Every year, FDA and key worldwide regulatory authorities perform foreign inspections of production facilities around the world. All inspections share a common goal: to ensure the products shipped to their respective countries will comply with the core requirements for safety, efficacy, quality, purity, and regulatory commitments. While foreign regulatory agencies merit respect, the FDA and U.S. cGMP are the standard for regulatory oversight and compliance requirements for global companies supplying the U.S., as well as the gold standard for their foreign markets as well. Unlike inspections performed at U.S. domestic facilities, special arrangements are required to ensure the successful completion of foreign inspections. This article will focus on the processes and approaches followed by the U.S. Food and Drug Administration to fulfill its statutory obligations to enforce its regulations and to protect the well being of the American public…read the full article at