The United States Food and Drug Administration (FDA) recognized that regulatory barriers have inhibited adoption of state-of-the-art manufacturing practices within the pharmaceutical industry. A new risk based approach for Current Good Manufacturing Practices (cGMP) looks to modernize the regulation of pharmaceutical manufacturing.
The FDA's initiative is built on the premise that if manufacturers can demonstrate understanding of their processes, they are at less risk of making bad product. Manufacturers can also benefit from new freedoms allowing them to implement improvements based on their process knowledge without the need for regulatory review.