Tag: pharmaceutical quality

Manufacturing Changes: Notification and Approval Requirements for Pharmaceutical Quality

Understand the FDA's three-tier system for manufacturing changes in pharmaceuticals: major, moderate, and minor. Learn what triggers approval, notification, and annual reporting - and how to avoid costly regulatory mistakes.

China and India Manufacturing: Risks and FDA Monitoring in Pharmaceutical Supply Chains

China and India dominate global pharmaceutical manufacturing, but FDA monitoring reveals stark differences in compliance. India leads in regulatory reliability, while China offers scale at higher risk. Here's what you need to know about drug safety and supply chain risks.