EudraLex – Volume 4 Annex 1: Environmental Monitoring and Quality Control

How do cleanrooms maintain their high level of sterility, and where do the guidelines come from? Join Tian, an Environmental Monitoring Manager, as he takes you through the quality control guidelines outlined in EudraLex – Volume 4 Annex 1. Explore the attributes of an effective Contamination Control Strategy (CCS) and the essential elements of quality control effectiveness necessary to ensure the sterility of production environments. Through practical examples like bioburden and sterility testing, continuous particle monitoring, and Aseptic Process Simulation (APS), this course illuminates the multi-layered approach to safeguarding the integrity of medical products and, ultimately, protecting patients.