From Regulation to Application: Best Practices in Nitrosamines and Polymorphic Impurities Webinar
Join our team of specialists for a focused and practical live webinar on Nitrosamines and Polymorphic Impurities.
Risk assessing impurities in drug substances and finished products is essential for regulatory compliance and patient safety. This session will highlight key aspects of ICH M7 (nitrosamines) and ICH Q6A (polymorphic impurities), providing clarity on current expectations and best practices for product risk assessment.
With over 15 years of combined expertise in LC-MS/MS and X-ray diffraction, our experts will guide you through efficient analytical strategies, illustrated with real-world case studies that show how regulations are applied in practice. Whether you are developing new products or maintaining compliance for existing formulations, this session will help you strengthen your impurity risk assessment approach.
What You’ll Learn:
By attending this webinar, you will:
- Understand how to assess nitrosamines (ICH M7) and polymorphic impurities (ICH Q6A) in drug substances and products.
- Gain clarity on evolving regulatory expectations and how they affect product development.
- Discover proven strategies for impurity analysis using LC-MS/MS and X-ray diffraction.
- Learn from real-world examples that illustrate challenges and solutions in impurity risk assessment.
Why Watch?
Understanding how to identify and control impurities in drug products is essential for both patient safety and regulatory approval. By joining this webinar, you will benefit from the insights of seasoned experts who have guided pharmaceutical companies through impurity risk assessments for over 15 years. The session will highlight how to interpret ICH M7 and Q6A requirements, translate them into practice, and adopt strategies that improve both efficiency and compliance. From new product development to lifecycle management, you’ll walk away with actionable knowledge that strengthens your approach to impurity profiling.
Cormica’s mission is to improve patients’ lives by providing comprehensive testing services, enabling clients to launch and release their products safely and rapidly across the world.
With Cormica as your partner, you can confidently outsource your impurity testing to a laboratory with deep regulatory knowledge and technical expertise. Whether you are developing a new drug product, conducting a risk assessment for existing formulations, or responding to updated ICH guidelines, our team is here to support your analytical needs. Contact us to discuss how we can assist with your impurity profiling strategy at sales@cormica.com
Authors:
Caroline German
Operations Director - Cormica Bradford
Caroline German, PhD FRSC, is Operations Director at Cormica Bradford with over 25 years’ experience in analytical chemistry, physical characterisation, and GMP. She has led multidisciplinary teams in method development, validation, and testing, with expertise in X-ray diffraction, particle analysis, and thermal analysis.
Sarah Soutar
Analytical Scientist - Separation Sciences
Sarah Soutar is an Analytical Scientist at Cormica Bradford and has over 8 years’ experience in Life Sciences. She specialises in LC-MS, particularly it’s applications in trace-level impurity analysis. She is dedicated to enhancing safety standards and contributing to regulatory compliance through innovative analytical techniques. Her expertise supports the development of high-quality, compliant testing solutions for Cormica’s clients.