Overview
Control of impurities in drug substances and drug products is very critical in assuring their quality. Types of impurities in finished product on its manufacturing process more so for drug substances. Systematic approach to identify potential impurities and define specifications of APIs which are generally made by multistep synthetic processes and also to define impurity specifications of drug products. The discussion will cover organic impurities, degradants and genotoxic impurities. Strategies to fix limits for these impurities will be discussed.
Why you should Attend
Control of impurities during the manufacture of drug substances and drug products is very critical and hence a knowledge of strategies for identifying potential impurities and fixing appropriate limits is very essential.
Areas Covered in the Session
Who Will Benefit
Dr. Ganesh Prasad is a freelance Pharma consultant in India under the banner ‘Q_Pharma consulting India & holds a doctorate degree in Organic Chemistry from Indian Institute of Science, Bengaluru. Previously, he worked at senior levels in pharmaceutical companies like Apotex Pharmachem India Pvt Ltd, ICI Pharmaceuticals, India and other organisations heading QA/QC/Process functions. He has also worked as scientist in the US FDA laboratory in Washington and other reputed institutions in USA/ Canada/India. He has together more than 30 years of experience together in quality assurance function, research in academia and industry. As a consultant he has assisted many pharmaceutical companies towards establishing cGMP standards of US FDA, European and Indian regulatory agencies. He also conducts third party quality audits of pharmaceutical manufacturers. He has conducted many public and in-house workshops and delivered invited lectures in forums like UBM, ISPE, DIA and so on.