Risk-Based Approach

Within an established quality system and for a particular manufacturing process, one would expect an inverse relationship between the level of process understanding and the risk of producing a poor quality product. For processes that are well understood, opportunities exist to develop less restrictive regulatory approaches to manage change. Thus, a focus on process understanding can facilitate risk-based regulatory decisions and innovation. Note that risk analysis and management is broader than what is discussed within the PAT framework and may form a system of its own. This is currently under discussion as part of the broad FDA Risk-Based initiative.