FDA's RISK-BASED QUALITY INTIATIVE
This article was originally published in The Gold Sheet
...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.]
You may also be interested in...
Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.
Using QbD to set specs that make a difference to patients is hard but important work, FDA's Woodcock says. Prasugrel, levothyroxine, pallodone examples explored. How to establish a 'work space.' How to make the right correlations.
As biotech firms begin to pilot QbD they wrestle with FDA over non-critical process parameters, postapproval changes and more. They are exploring how to define design spaces, change them, identify their edges. And they're still wondering what regulatory relief they might get in return for investing in quality-by-design studies.