Introduction to GXPs

The pharmaceutical industry is tightly regulated, allowing the commercial sale of medicinal products only if regulatory requirements are met. This course emphasizes the US FDA GXPs that apply to managing quality within the pharmaceutical, chemical, and biotechnology industries and touches on differences between the other regional markets in the rest of the world. Students will gain an introduction to Good Practices (or GxPs) including Manufacturing (GMPs), Clinical (GCPs), Laboratory (GLPs), and Automated Manufacturing (GAMPs), and will explore the lifecycle of a drug, from development through to commercial production.