Almost any discussion today about what regulatory focus is and where it might be going, inevitably becomes a discussion about Risk Management. Almost 1 12 years after the FDA announced their initiative on Risk Management for pharmaceuticals and biologics, many companies are still in the process of understanding the ultimate goals that the FDA hopes to achieve. Of course, one of the main questions they ask is, “What do I have to do differently to be in compliance?” Interestingly for most companies, the answer has evolved only slightly from when the FDA first announced the initiative. A common initial reaction was to take a wait-and-see approach and “do nothing different.” However as the FDA has been sharing its progress on its website and through public meetings, companies have now begun to better understand the impact on their business and are weaving the concepts of FDA Risk Management into their strategic Quality & Regulatory initiatives.
While not well understood by many, the FDA has always put a strong emphasis on using Risk Management techniques. Properly applied, these techniques are commonly used by the FDA to ensure the health and safety of patients and consumers of pharmaceuticals, medical devices, diagnostics, foods, and cosmetics. As a result, the initiative on Risk Management was not intended to rewrite regulations, but to ensure that in an increasingly more complex world and global marketplace, focus was drawn to the critical few as they could be hidden amongst the trivial many.
Besides assisting companies in determining how to focus on areas of high-risk, another of the FDA’s reasons for the Risk Management initiative was to ensure that their own staff and resources continue to focus on critical areas when the need arises. As I am writing this article, we find ourselves in the midst of a real world example of how the Risk Management process can help in this effort. With the first reported US case of BSE (Bovine Spongiform Encephalopathy), a major FDA effort is underway (in conjunction with several other regulatory agencies) to ensure that this is a truly isolated case and is rapidly resolved. Risk Management techniques allow these agencies to quickly refocus resources on the problem while at the same time ensuring that they continue to apply appropriate levels of effort and resources to their other patient/product safety and efficacy duties.
The FDA Risk Management initiative places a high priority on the risks that are inherent with sterile products and claims of sterility or cleanliness. As such, contamination control methodologies that also strategically employ Risk Management techniques now become an incredibly effective and powerful means of demonstrating compliance to the FDA. Techniques that previously could only provide evidence of contamination control, with effective risk mitigation can now evolve to new and effective methods that demonstrate contamination levels are assured to appropriate and acceptable levels. Some may argue that there is not an immediate advantage of achieving such assurance levels for today’s well-established products and processes. However it is a certainty that as technology continues to advance, new types of products and processes will create unforeseen challenges providing assurance of validated contamination control.
In summary, companies involved in contamination control who have not previously done should consider investing some time to understand the intent and potential benefits of the FDA’s Risk Management focus. As the FDA continues to make this one of its highest priorities, the time invested today will pay off handsomely in the future.