EudraLex – Volume 4 Annex 1: Pharmaceutical Quality Systems and Contamination Control Strategies

The way that a pharmaceutical manufacturer maintains the sterility of their processes and products doesn’t occur by chance. Instead, it’s part of a comprehensive system derived from the principles of EudraLex Volume 4, Annex 1. In this course, you’ll explore the foundational role of the Pharmaceutical Quality System, its framework, its relationship to Good Manufacturing Practice, and Quality Risk Management. You’ll also learn how all these systems come together in the form of a company’s Contamination Control Strategy, including personnel training, environmental monitoring, and equipment qualification to ensure the production of safe and sterile pharmaceuticals.