Quality and compliance in the Pharmaceutical industry: issues and perspectives

Abstract: The pharmaceutical industry is subject to a number of regulations stipulated by Food and Drug Administration (FDA) and other regulatory authorities. These regulations enforce strict quality standards on pharmaceutical companies to ensure the safety and benefits of the products made by them. Quality management in the industry goes beyond ISO expectations and is much more complex and pervasive in scope necessitating significant investment of time, efforts and resources. Faced with the challenge of meeting complex FDA regulations, pharmaceutical companies are investing substantial resources in the development and implementation of an Enterprise Quality Management (EQM) strategy.