Pharmaceutical Current Good Manufacturing Practices (cGMPs) in the United States (FDA) and Europe (EMA): Similarities and Differences

Pharmaceutical current Good Manufacturing Practices (cGMPs) are in effect in 104 countries, either through national codes, adherence to regional codes, or adoption of the WHO code. The United States Food and Drug Administration (FDA) and Europe’s European Medicines Agency (EMA) are two of the major global bodies that oversee pharmaceutical cGMPs. Participants in this course will learn similarities and differences between the FDA and EMA cGMP terminology and regulations, including cleanroom standards, environmental monitoring practices, the roles of the Quality Assurance Director (FDA) and Qualified Person (EMA), internal audits, and contract manufacturing.