Pharmaceutical Regulatory Affairs and IPR

GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries. The purpose of the GMP regulations and quality management system is to ensure that a product is safe and meets its intended use. Quality management system has four main components: quality planning, quality assurance, quality control and quality improvement. Quality audit is the process of systematic inspection of quality management system which is carried out by an internal or external auditor or an audit team. It is an important part of organization's quality management system and is the major part of GxP/GMP regulations. In this keynote speech, I will describe the framework of GxP/GMP regulations, quality management system, and quality audit.