Nitrosamine Advance Workshop 2024, conducted on May 9th and 10th at Radisson Blu Mumbai International Airport, has emerged as a watershed moment in the pharma industry boosting collaboration and innovation in the detection of the Nitrosamine landscape. Our workshop leaders and speakers brought their expertise in presence of over 70 delegates and the event offered an in depth exploration of nitrosamines, covering both updated regulatory guidelines and analytical understanding while also allowing participants to engage in practical discussions, case study-solving sessions, and hands-on learning Opportunities.
Day 1 : Exploring Foundational Concepts and Regulatory Framework
The inaugural day of the event commenced with ceremonial lamp-lighting graced by eminent personalities such as Dr. BM Rao CEO QDots Associates, Mr. Igor Gorsky, Principal Consultant, ValSource, Mr. Chetananand Pathak, Senior Director Quality, Emcure Pharma, Dr. Aruna Khanolkar, Director QbD, Cipla, Ms. Guneet Kaur Hayer, Managing Director of Eminence Group.
Ms. Guneet Kaur Hayer, Founder and Managing Director of Eminence Group, delivered an inspiring welcome note, underscoring the significance of Nitrosamine and their key challenges and also welcomed attendees & workshop leaders to set the tone for the event.
Workshop by Dr. BM Rao
Dr. BM Rao, CEO QDots Associates addressed participants on the overview and impact of Nitrosamine, their formation pathways and their significance keeping industry framework in mind. He also spoke about the global regulatory guidance from Health Canada on Nitrosamine impurities in medicines. He also gave the overview of WHO draft working document published in April 2024. Also, he discussed the set and evolving guidelines around Nitrosamine with updates from EMA- Nitrosamine/NDSRIs (from Rev 16 to Rev 20). Dr Rao, also conducted a case study on regulatory compliance and real-world scenarios of regulations and responses to nitrosamine contamination incidents, highlighted the best practices and lessons.
Industry Presentation
Purushottam Sutar, Deputy Manager- Pharma (LC, LCMS)& Consumables Market, Shimadzu Analytical India Pvt Ltd, spoke about Nitrosamine &; NDSRI Challenges. He also highlighted the industry is facing the issue of NDSRIs with many being reported with increasing frequency. He also spoke about shimadzu's Ultra-Fast Mass Spectrometry (UFMS) technologies LC-MS/MS, powered by Analytical Intelligence, offer a comprehensive solution for precisely quantifying trace amounts of these impurities in various pharmaceutical products.
Bringing Together Different Perspectives
Panel Discussion: Future Regulatory Trends on Nitrosamine Possibilities and Certainties
This session focused on the evolving regulatory landscape concerning nitrosamines, which are chemical compounds of concern due to their potential carcinogenic effects. The discussion focused on identifying future trends in regulation, assessing both the possibilities and certainties in regulatory approaches, and understanding the implications for the pharmaceutical industry. This powerpack session was moderated by Mr. Chetananand Pathak, Senior Director, Emcure Pharma, Dr. BM Rao, CEO, QDOT Associates, Dr. D Vijaya Bharathi, VP of Analytical Solutions, Aragen Lifesciences, Mr. Shital Pathak, SVP- Analytical R&D, Glenmark Pharma, Mr. Prashant Holkar, APAC Commercial Quality Head, Sandoz
Shimadzu Facility Tour
Our delegates got an opportunity to explore Shimadzu & Customer Support Centre for hands-on lab experience and cutting-edge insights that showcased their latest analytical technology &; analytical game in specially designed Q&;A Session.
Day 2 : Exploring Analytical Concepts and techniques for Nitrosamine Detection Workshop by Dr. Somenath Ganguly Dr. Somenath Ganguly, AVP, Sun Pharma addressed participants with indepth exploration of analytical techniques and methods for detecting and quantifying nitrosamine compounds while keeping focus on latest advancements and best practices , and also discussed about considerations for method development, validation, and ongoing quality assurance. Dr. Ganguly also presented a case study on Data Interpretation (API Drug Formulation Relationship) and group activity based on method development for nitrosamine analysis &; also offered guidance on managing and responding to regulatory queries.
Industry Presentation: Dheeraj Handique, Manager – GC/GCMS Product Marketing for Shimadzu Analytical (India) Pvt. Ltd addressed Nitrosamine Challenges using Shimadzu GC-MS/MS with UFMS technology. He also spoke about the contamination in valsartan API from a Chinese manufacturer in July 2018 and how Shimadzu & Ultra-Fast Mass Spectrometry (UFMS) technologies GC-MS/MS powered by Analytical Intelligence, offers comprehensive solution for precisely quantifying trace amounts of these impurities in various pharmaceutical components.
Understanding Toxicity & Risk Assessment Strategies.
Dr. Ashutosh Joshi, Principal Scientist, Dr. Reddy’s. This discussion delved into advanced detection methods, explores their toxicity mechanisms, navigates regulatory landscapes, and presents techniques for successful risk assessment and understanding the role of TD50 in toxicological evaluations and regulatory compliance. Acknowledgments: Celebrating Partnerships and Collaborations The success of the event was made possible by the unwavering support and collaboration of our esteemed partners Shimadu, Sciex and Pragvas & Media Partners for their invaluable contributions and commitment to advancing quality standards in the Pharma industry.
Conclusion : Inspiring Change and Driving Transformation As the Nitrosamine Advance Workshop 2024 concluded, participants departed with a rejuvenated feeling of commitment and motivation. The event provided valuable talks, collaborations, and practical insights, paving the road for positive change and transformation in the pharma quality landscape.
