In the EMA newsletter published in September 2019, the pharmaceutical industry received a significant wake-up call regarding the need to evaluate the risk of nitrosamine impurities in human medicinal products containing chemically synthesized active pharmaceutical ingredients. This directive has prompted a thorough review process to ensure the safety and compliance of medicinal products.
This presentation will delve into case studies of analytical testing related to the three-step process requested by EMA and FDA to assess the risk of nitrosamines in medicinal products. By examining real-world examples, attendees will gain a comprehensive understanding of the methodologies and challenges involved in identifying and mitigating the presence of these impurities.
The three-step process includes an initial risk assessment to determine the potential presence of nitrosamines, followed by confirmatory testing to identify and quantify any impurities detected. The final step involves implementing appropriate measures to control or eliminate the risk, ensuring that medicinal products meet stringent safety standards.
Through detailed case studies, the presentation will highlight the practical aspects of conducting analytical testing for nitrosamines, showcasing successful strategies and common pitfalls. Attendees will learn about the importance of a thorough risk evaluation and the role of advanced analytical techniques in detecting even trace levels of impurities.
This webinar is essential for professionals involved in pharmaceutical manufacturing, quality assurance, and regulatory compliance. By attending, participants will be better equipped to navigate the complex regulatory landscape and implement effective risk management practices to ensure the safety of their products. Understanding the EMA and FDA requirements and learning from real-world applications will provide valuable insights into maintaining compliance and protecting public health.