Increased regulatory oversight in the past year or two has forced quality, regulatory, and compliance personnel to be on their toes. And that's a good thing in terms of ensuring quality and, ultimately, protecting patients and end-users. However, it's not without its headaches—particularly when facing an increasingly demanding and inconsistent inspection environment.
The key to inspection preparedness, however, is to cultivate a culture of quality within an organization rather than a culture of compliance, according to Dennett Kouri, senior director, quality, regulatory, and clinical at Edwards Lifesciences. Kouri, who will be presenting on, "Being audit-ready at all times in an inconsistent inspection environment," at MD&M West on February 11, explains that a culture of quality is characterized by the mindset, "this is how our organization operates on a day-to-day basis under the confines of our quality management system," rather than approaching every day as if, "we're just trying to get ready for the next inspection."
Beyond building a culture of quality, industry can more nimbly navigate the somewhat-volatile inspection process by being aware of patterns and trends that have emerged in recent months as part of increased oversight. Here are six that Kouri has his eye on.
1. Variation in investigator experience. "The most important aspect of an inspection and the most unknown is who actually walks through the front door," Kouri says. "FDA has made a concerted effort to bring on new investigators over the last several years to make sure it has more coverage. While it's a great [trend], we do have varying levels of investigators doing audits as a result."
Because you never know if your investigator will be a newbie or a seasoned vet, you need to "prepare for the worst and hope for the best," according to Kouri. In essence, keep it simple and practice explaining the organization and processes as if doing so for a layman or novice. Of course, modify the strategy if the investigator turns out to be experienced.
Kouri also notes that the combination of an inexperienced investigator with an inexperienced subject matter expert can be problematic. In this situation, experienced leads are critical. "[They can] help to manage the discussion to make sure the conversation and the interview is helpful to the investigator and to help get to the point as quickly as possible."
2. Heightened scrutiny of purchasing controls. "I think there's a bigger focus now on initial selection criteria and evaluation of suppliers than there has been in the past," Kouri observes. He adds that, even if suppliers have been working with the company for some time, FDA is questioning the basis for selection and whether they possess a quality management system that is appropriate for what they are supplying to your company.
3. Elevated expectation of thoroughness and supporting documentation. FDA is keeping a closer eye on the adequacy of investigations, whether pertaining to nonconformances, CAPAs, or other issues. In addition to a robust investigation, FDA increasingly expects an extensive paper trail documenting the investigation. "It's like the old adage: If it wasn't written down, it didn't happen," Kouri says.
4. Increased emphasis on timeliness of responses and investigations. Investigators are sending a clear message: Quality and compliance issues must be dealt with in a timely manner—especially in the case of complaints, MDRs, and health hazard assessments.
5. Emerging focus on product in commercial distribution. When it comes to problems with products on the market, industry experts have noticed a changing attitude. FDA is increasingly cracking down on companies to conduct in-depth investigations to identify the root cause of the issue—thereby removing it from the commercial world—and resolve it expediently.
"In the past, there has been more reliance upon the safety aspects of the product and a good track record versus a strict adherence to GMP requirements," Kouri states. "But FDA has been transitioning more toward [the stance]: If you don't comply with GMP along the way and you don't have evidence to demonstrate compliance along the way, the fact that the product is performing well in the market is not going to carry the day anymore."
6. Mounting emphasis on management awareness. "We've also seen and heard that [investigators] are really trying to make sure that management is up to speed with what's going on, that it's being presented with all of the information needed to make the appropriate decisions along the way," Kouri says, adding that evidence to support such claims and actions is essential. "So, the overall message here is for industry to make sure it's ready for a deeper dive into the records with respect to CAPAs, MDRs, out of specifications, and all of those quality records—all with an eye toward the adequacy of management's oversight."
Shana Leonard is vice president, content, at UBM Canon. Reach her at [email protected]