BENG 6310
CMC Regulations of Pharmaceuticals

Regulatory Chemistry, Manufacturing and Control (CMC) requirements determine the strategy parameters for new pharmaceutical process development and changes post approval. Knowledge of CMC requirements and relevant agencies is a key success factor in pharmaceutical approval and compliance. In particular, globalization has caused a significantly more complex regulatory environment for the manufacture and distribution of pharmaceuticals (and medical devices). Most product supply chains are now multinationals with an increasing trend towards investment in rapidly developing but poorly regulated nations.

The development of regulatory strategies for product development and post approval changes require the understanding of many national regulatory agencies and international harmonization efforts. Often the introduction of product production and distribution improvements is limited by the effectiveness of the Chemistry, Manufacturing and Control (CMC) regulatory strategy employed by the firm.

Effective CMC organizations coordinate with global regulatory agencies to develop risk-based approaches to inspection frequency and focus. Similar risk-based approaches are developed with global regulatory agencies to detect and prevent counterfeiting and product diversion.

Professionals knowledgeable in the principles and practice of regulatory CMC requirements are in high demand and hold positions of significant responsibility within the private and public sectors of the healthcare industry. The primary goal of this course is to provide students with an advanced background in the principles and requirements of regulatory CMC including Post-Approval reporting requirements, Deviation reporting, Inspection coordination and resolution, and Good Distribution Practices (GDP) practices. Through a series of lectures and case studies, this course will teach the critical thinking and judgment skills that are required for the development of CMC regulatory strategies and influence.

Biocon Academy students only