Organic

The Science and Strategy of Pharmaceutical Process Chemistry: Adapting to Global Regulatory Development Guidance on Process Impurities (#242)

The goal of this symposium is to bring together leading pharmaceutical process chemists and regulatory leaders with experience in obtaining regulatory approval for commercial manufacturing processes for drug substance. The session's main focus will be centered on impurity control as related to new regulatory guidance's. The program will include four sessions covering the following areas:

Address real, global examples of successes and challenges faced in developing commercial manufacturing chemical processes/ routes, while focused on strategies and technologies used for impurity control to meet expected quality limits of the final drug substance.

Highlight cutting edge chemistry, new technologies, process analytical technology (PAT), alternative purification methods, and a variety of others approaches used to meet the current expectations.

Interface of Regulatory and Industry: Highlight real cutting edge case studies on how process chemistry is developed to establish an appropriate control strategy and scientifically justified in regulatory submissions; exploring both the industrial and regulatory scientistsí perspective.

New regulatory guidance to be illustrated in presentations and case studies: International Conference on Harmonization (ICH- http://www.ich.org/) ICH Q11 quality guideline on the Development and Manufacture of Drug Substances, ICH M7; Assessment and Control of DNA Reactive (Mutagenic) Impurities in the Pharmaceuticals to Limit Potential Carcinogenic Risk

Last update: Dec 28, 2015