Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach
An effort to enhance and update the regulation of manufacturing processes and end-product quality of animal and human drugs and biological medicines is announced, the Pharmaceutical cGMP initiative. The goals of the initiative are to focus on the greatest risks to public health in manufacturing procedures, to ensure that process and product quality standards do not impede innovation, and to apply a consistent approach to these issues across the FDA .