May 8th – 9th, 2025 | Virtual Conference
The 3rd Annual Pharma Impurities Conclave 2025 successfully gathered analytical, formulation, and quality professionals from across the pharmaceutical industry for two immersive days of knowledge exchange, problem-solving, and regulatory insights. With impurity concerns growing more complex under global scrutiny, the event addressed a wide spectrum of impurity control topics from nitrosamines and genotoxins to AI-driven prediction tools.
This virtual edition set the stage for a deeper in-person engagement planned for September 2025, it was a powerhouse of expert guidance, technical training, and real-world case applications.
Key Themes & Learnings
Highlights from Day 1: Understanding the Impurity Landscape and their Impact
The day began with opening remarks and a guided orientation to the interactive portal, ensuring attendees made the most of the virtual platform.
Decoding Regulatory Complexity
Dr. Somenath Ganguly kicked off with a comprehensive guide to global impurity regulations. He reviewed updates from the FDA, EMA, and ICH, emphasizing India’s responsibility as a global pharma hub in aligning with Q3 and M7 standards. His session highlighted practical approaches to vendor qualification and managing international regulatory expectations.
Navigating NDSRIs
Dr. B.V. Ravichandra delivered a focused session on Nitrosamine Drug Substance-Related Impurities (NDSRIs). Using analogies and scientific nuance, he walked attendees through classification frameworks, CPCA logic, and toxicological profiling.
Risk-Based Impurity Control in Dosage Forms
In an engaging, group activity-based session, Dr. Praveen Cherukupalli dissected real-life case studies to explore risk assessment and impurity control plans, helping attendees translate guidelines into daily operations.
Impurity Profiling in Complex Molecules
Mr. Shailesh Buha delivered a two-part series on types and sources of impurities, particularly in liposomes and complex molecules. His sessions encouraged participants to find the odd man out in impurity types and build tailored mitigation strategies.
Raw Materials and Upstream Control
Dr. Narender Rao Somisetti addressed the often-overlooked role of raw materials in impurity creation. Through lessons from past incidents like the Heparin and Sartan recalls, he emphasized robust auditing and data tracking for upstream safety.
Day 2: From Analytical Innovation to Documentation Integrity
The second day opened with a recap and quickly moved into high-impact technical sessions.
Analytical QbD and Method Optimization
Dr. Manoj Kumar Singh presented a sharp overview of AQbD, guiding participants through designing impurity detection methods based on critical quality attributes (CQAs) and performance metrics.
Mass Spectrometry & Non-Targeted Analysis
Dr. Manish Kumar Dare introduced attendees to Non-Targeted Analysis (NTA) and Suspect Screening Analysis (SSA), enhancing how analytical teams can detect unknown or trace-level impurities.
AI in Impurity Prediction
Dr. Ravi Shekar Ananthula offered a futuristic lens into AI-based impurity prediction and inverse structure elucidation. His session showcased how AI can reduce drug recalls by predicting and tracking impurities throughout the development cycle.
Learning from the Past: Case Study Reviews
Mr. Parminder Singh Bhasin led a session analysing past drug recalls and the regulatory responses that followed. His talk emphasized building forward-looking compliance strategies through root cause analysis.
Documentation Excellence in Analytical R&D and QC
Continuing the compliance focus, Mr. Parminder Singh Bhasin explored documentation lapses highlighted by 483s and warning letters. His practical guide emphasized close alignment between R&D and QC teams to ensure regulatory-ready documentation practices.
Interactive Elements & Audience Engagement
Attendees actively participated in hands-on workshops, case-solving activities, anonymous Q&A sessions, and group-based risk evaluations. From portal networking to expert-led discussions, engagement remained high throughout the event.
Conclusion: Advancing Quality Through Knowledge
The 3rd Annual Pharma Impurities Conclave 2025 proved to be an impactful platform for continuous learning, skill-building, and strategic clarity in impurity management. With its emphasis on AI, analytical rigor, and real-time problem solving, the event reaffirmed the industry’s shared goal: to reduce risk, ensure safety, and uphold the integrity of pharmaceutical development.
