High vs Low-Risk Vendors: How to Categorize and Qualify Suppliers in Pharma How to Categorize and Qualify High vs Low-Risk Vendors in Pharma Supplier qualification is a foundational element of pharmaceutical quality systems. In an era of globalized sourcing, it’s no longer enough to qualify every vendor equally. Regulatory agencies, including the FDA, EMA, and ICH, now emphasize a risk-based approach to vendor qualification and lifecycle management. This means vendors must be categorized based on their risk impact to product quality, patient safety, and regulatory compliance. This article provides a full guide on how to classify suppliers as high or…