FDA's RISK-BASED QUALITY INTIATIVE
This article was originally published in The Gold Sheet
Executive Summary
...is designed to ensure that the various GMP and CMC programs the agency has launched for improving the regulatory framework are integrated, systematized and strengthened. The new initiative is based on the principle that unleashing analytical technology is the most effective way to manage risk and streamline the quality regulatory process. With FDA and industry management backing, the vision of a new manufacturing and control paradigm is becoming a reality. [FDA policy developments since 1995 leading to the risk-based initiative are outlined.]