Managing Nitrosamine Impurities: A Review of the Current Regulatory and Pharmacopeial Framework

Nitrosamines-The LC/MS Edge - The Compliance Code:

Global regulatory authorities, including the FDA and the EMA, have introduced major regulatory updates instructing all drug manufacturers to conduct a risk assessment and proactively test their products for nitrosamine impurities. This webinar will cover the latest regulatory updates on nitrosamines impurities in drugs, which require all drug manufacturers to perform a risk assessment and test their products for these impurities.

The webinar will also update the participants on the current regulatory framework and compendial solutions for nitrosamine impurities.

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Key Learnings:

• The latest regulatory updates from the EMA, FDA, EDQM, and USP on nitrosamine impurities
• The best practices for conducting risk assessment and testing for nitrosamine impurities
• The compendial testing requirements and solutions (USP’s documentary and reference standards) for nitrosamine impurities
• The ongoing activities and future strategies of USP to control nitrosamine impurities in human drugs

Presenter: Dr. Rahul Dev (Vice President and Head Analytical Research - API & Formulation, Mankind Research Centre)

Dr. Rahul Dev is focused scientist with 30+ years of experience in managing functions related to Analytical Research & Development. His expertise include Analytical method development for APIs, NCEs, Vitamins, Peptides, Advance Intermediates, Agrochemicals etc., Impurity Profiling, Characterization & evaluation of GTIs, Elemental & Nitrosamines impurities in APIs & Drug Products (Solid oral, Ophthalmics/Otic ,Injectables, Creams, Ointments, Gels) & Microbiological tests.

Designing and execution of protocols and reports for analytical method in compliance with various regulatory guidelines cGLP, ICH, USFDA, OECD & REACH for registration purpose & release of related technical reports/detailed documentation as per need of technology transfer.

Presenter: Dr. Mayank Bhanti (Director, Compendial Development Laboratory, United States Pharmacopeia)

Dr. Mayank Bhanti has been with USP since 2019 and leads a team of scientists involved in the modernization of monographs for Small molecules (drug substances and drug products), Excipients, and Food ingredients.

Dr. Bhanti obtained his Ph.D. from Dr. B.R. Ambedkar University, Agra, and acquired General Management certification from IIM, Ahmedabad, under the Senior Management Programme (SMP). He has around 20 years of experience in Analytical R&D with a specialization in trace analysis. He has authored many publications and peer-reviewed articles.

Dr. Mayank Bhanti is also an approved instructor (faculty) for USP education courses and delivers courses across the globe. He is also part of USP’s Nitrosamine Impurities Workstream.Prior to joining USP, he was associated with different contract research organizations, testing, and certification laboratories.