Mitigating HCP Risks Throughout the Product Life Cycle

Based on product development and the manufacturing experience, many examples are known where HCPs could severely impact patient safety. Therefore, the tight control of HCPs is an important issue for many product classes. The removal and control as well as the characterization of HCPs are important measures to guarantee high quality and safe biomedicines. This primary goal is supported by EU and US guidelines providing effective tools to circumvent hurdles during the licensing process. State-of-the-art control strategies during product development and throughout the product life cycle are required to be implemented. An HCP risk assessment should complement the studies. In this presentation, the understanding of the regulatory decisions will be facilitated by case studies.