Nitrosamine Safety Developments, Guidelines, and Challenges

Dr. Ravichandra is a veterinarian with a specialization in veterinary pharmacology and toxicology. He is an American Board-Certified Toxicologist (DABT) and a European Registered Toxicologist (ERT) with over 17 years of experience in global pharmaceutical development. He currently leads Global Toxicology & Nonclinical Development at Amneal Pharmaceuticals. He has contributed to IND, NDA, ANDA, and DMF submissions across Amneal, Elanco, Dr. Reddy’s, Cipla, and others. His expertise spans impurity qualification, nitrosamines, (Q)SAR, HBELs, E&L, and biowaiver strategies. He has served on ICH veterinary working groups, contributed to ELSIE, and worked with JECFA/FDA on food safety as well. He is a co-inventor of 3 international patents and has 19 publications in peer-reviewed international journals.

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Dr Ashutosh is a veterinarian by education and currently working as a Lead – Nonclinical Development and Risk Assessment in Dr Reddy’s Labs

He is an American and European Board-certified Toxicologist (DABT and ERT)

He has more than 18 years of diverse experience of non-clinical drug development for generics, NCEs, complex generics, and small peptides, for different markets

He is extensively involved in conducting risk assessments & safety evaluations for different types of impurities, excipients, E&L compounds

He undertakes Environmental Risks Assessments and derivation of Health Based Exposure Limits (OEL & PDE)

He is required to regularly interact with different regulatory agencies across the geographies and is also member of selected consortium and scientific panels.

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Rajendra is currently working as a Group Leader of Analytical Research at Wockhardt Research Centre, Chhatrapati Sambhajinagar, Maharashtra, with over 29 years of experience in analytical research in the pharmaceutical industry. He holds a Ph.D. in Organic Chemistry from Dr. Babasaheb Ambedkar Marathwada University, Chhatrapati Sambhajinagar.

He specializes in impurity qualification and characterization, using chromatographic (HPLC, GC) and spectroscopic (NMR, Mass, IR) techniques for method development, validation and data interpretation, ensuring regulatory compliance and product quality.

Dr. Chavan actively contributed to the development of the USP Nitrosamine Guideline in December 2022 and received recognition for his efforts. He has published several research papers in esteemed peer-reviewed journals, including those from Taylor & Francis, Springer and MRI Publications. His work has significantly advanced the understanding and management of impurities in pharmaceuticals.

Beyond work, Rajendra enjoys trekking and playing chess and is married to Mohini with two children, Pratyusha and Parikshit.

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Dr. Ashok Chaudhari serves as Associate Director at Emcure Pharmaceuticals Limited, heading the Sophisticated Instrument Facility in the API Research Centre. With a Ph.D. from Savitribai Phule Pune University and 30 years of industry experience across Lupin Laboratories, Unimark Remedies, Aurobindo Pharma, and Emcure, he has established himself as an analytical research expert. Dr. Chaudhari has isolated and characterized over 4,000 pharmaceutical impurities, published more than 15 international papers on impurity characterization, and holds three patents for peptide purification using preparative HPLC. His contributions continue to advance pharmaceutical analytical methodologies and quality standards.

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Dr. B.M. Rao is an accomplished pharmaceutical quality expert with over 33 years of leadership in Analytical R&D and Quality Control at leading companies such as Dr. Reddy’s, Janssen (J&J), and Novartis. A recognized authority on data integrity, regulatory readiness, and Nitrosamine assessments, he has actively supported global audits by USFDA, EMEA, and Health Canada. With 80+ scientific publications and ten Ph.D. mentees, he now serves as CEO of QDOT Associates, providing global consultancy services. Dr. Rao is also a seasoned international speaker known for delivering insightful sessions on GMP compliance and analytical excellence.

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Dr. Mrunal serves as Vice President of Research and Development at USP India, where she oversees a comprehensive R&D laboratory comprising the Compendial Development Laboratory, Analytical R&D, and Synthetic Chemistry Laboratory. With responsibility for Scientific Affairs and Strategy functions at USP India, she brings nearly three decades of pharmaceutical industry expertise to her leadership role.

Throughout her distinguished career spanning over 29 years, including 9.5 years with USP India, Dr. Mrunal has established herself as a preeminent figure in pharmaceutical analysis and research. Her expertise encompasses the development, validation, and transfer of stability-indicating analytical methods for drug substances and products. She has made significant contributions to the estimation of potential genotoxic impurities using advanced techniques such as LC-MS/MS and GC-MS/MS.

Dr. Mrunal leads the global Nitrosamine Impurities Workstream, where she has been instrumental in formulating USP's "Focused Nitrosamine Strategy." Her team's primary responsibilities include developing and validating analytical methods for monograph modernization, synthesizing bulk materials of impurities and APIs, and characterizing them to support the development of documentary standards for drug substances, drug products, excipients, and food.

Her exceptional contributions to the field have been recognized with prestigious accolades, including the 'Prof. Dr. R. T. Sane - Outstanding Pharmaceutical Analyst Award' at the 20th IDMA-APA Pharmaceutical Analysts Convention in May 2018, and the award for 'Excellent Contribution in field of Pharmaceutical Research' at the Health & Wellness Conclave in Dehradun in March 2021.

Prior to joining USP India, Dr. Mrunal successfully led Analytical Research and Development departments in various capacities across both Indian and multinational organizations, consistently demonstrating her expertise and commitment to advancing pharmaceutical science

Mr. Dheeraj Handique is currently working as Manager – GC/GCMS Product Marketing at Shimadzu Analytical (India) Pvt. Ltd., Mumbai, a role he has held since 2008. He brings with him over 23 years of rich experience in the analytical instrumentation industry.

At Shimadzu, Mr. Handique plays a vital role in both pre-sales and post-sales application support across key sectors including pharmaceuticals, chemicals, food safety, and the flavours & fragrance industry. His responsibilities span troubleshooting, method transfer, method development, and validation, with a focus on providing total system solutions for GC and GCMS/MS platforms. This includes configuration and integration of advanced accessories such as Headspace (HS), Thermal Desorption (TD), and Pyrolyzers.

He has authored and presented over 30 posters at international conferences, showcasing his deep domain expertise. His technical proficiency includes the analysis of pharmaceutical drug substances and products, as well as complex food and flavour matrices, using cutting-edge Shimadzu technologies like GC, GCMS/MS, HS, and TD. He is also well-versed in the critical sample preparation techniques that are essential to these analyses.

Mr. Handique is a recognized speaker and has delivered numerous lectures on Gas Chromatography, Mass Spectrometry, Headspace, and Thermal Desorption techniques at various national conferences. He is also actively involved in the performance evaluation and benchmarking of Shimadzu’s chromatographic and advanced analytical systems.

Dr. Santosh Bhardwaj is currently working as Manager – Business Development (Pharma & Consumables Market) at Shimadzu Analytical (India) Pvt. Ltd., Delhi, and has been associated with the organization since 2008. He holds a Ph.D. in Chemistry, an MBA in Operations, and an M.Sc. in Industrial Chemistry, With over two decades of experience in the analytical instrumentation industry.

Dr. Bhardwaj leads pan-India pre-sales technical support for technologies such as LC, IC, LCMS, LCMS/MS, and QTOF, with a strong focus on pharmaceutical applications. He also drives business development for LC/GC column chemistries and sample preparation solutions & Kits.

His core expertise lies in method / application development, demonstrations, method transfer, and troubleshooting, particularly in regulated environments. His domain strengths include impurity profiling, extractables & leachables (E&L) studies, and nitrosamine (NSA) analysis, providing tailored system solutions for both R&D and QC needs.

Dr. Bhardwaj has authored over 20 research papers and presented more than 30 posters at national and international conferences. He is recognized for his ability to deliver practical, high-impact solutions to complex analytical challenges.

Samanta Karwarkar is a seasoned CQA Professional and Computer System Validation expert with over 32 years of experience in pharmaceutical quality functions. Currently serving as Head-CQA at ACG - Associated Capsules, she leads the implementation of robust quality systems, data governance, and validation processes across India and international locations.

Throughout her distinguished career with both Indian majors and multinational pharmaceutical companies, Samanta has established and monitored quality systems for contract manufacturers and company-owned sites in Europe. Her expertise spans QA/QC operations, analytical development, and qualification and validation for both greenfield and brownfield projects.

Samanta has successfully led Computer System Validation teams for critical software implementations including SAP, QAMS, DMS, and LIMS, demonstrating her technical leadership and commitment to maintaining the highest quality standards in pharmaceutical manufacturing.