Nitrosamine Advance Workshop 2024 A Comprehensive Post-Show Review
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&
#39;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, SVPAnalytical
R&D, Glenmark Pharma, Mr. Prashant Holkar, APAC Commercial Quality Head,
Sandoz
Shimadzu Facility Tour
Our delegates got an opportunity to explore Shimadzu&
#39;s 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&
#39;s 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.
