Great quality is pretty much the same everywhere, but the cost of poor quality is not equivalent from industry to industry. For example, it’s conceivable (but I hope not probable) that this article may turn out to be a real bomb, or worse, a complete snoozer. What’s the cost of that poor quality? To you, the reader, it will likely mean little except some lost time. For me, as the writer, the reputational hit could be considerable. To Quality Digest, as the publisher of the piece, the fallout could be even worse—lost readers and advertisers.

Now consider the risks of poor quality for a company operating within the life sciences sector. For these organizations, poor quality can lead to deadly outcomes for customers. That’s why U.S. Food and Drug Administration (FDA) agents won’t hesitate to shut down organizations that have been warned about faulty procedures and bad quality but can’t or won’t correct the situation.

Compliance to FDA regulations is not optional for life science companies, and that’s a good thing. That absolute level of adherence does more than keep the FDA from closing manufacturing operations or even entire companies. The FDA also helps to ensure our safety as it regards to the things we eat and drink, or that doctors prescribe, inject, and implant. Complying with both the letter as well as the spirit of FDA requirements is the surest way to drive quality outcomes that benefit stakeholders both in and out of the organization.

Best practices

Great companies in this space understand the value of compliance in generating quality. They also, as it happens, value discretion and are notably protective of their proprietary processes.

With this in mind, I recently spoke to a senior manager of quality assurance at a clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies. My contact gave me some great insights, but on condition that I not name any names.

This life science manufacturer currently has a handful of therapeutic products in the clinical-phase pipeline and moving toward commercialization. Therefore, the company’s management team is intimately involved with quality best practices around research and development, and ultimately, testing and regulatory approvals.

“We’re really looking to support the clinical manufacturing of those products,” notes my source. “We understand the build of our quality system, starting with Quality by Design. Developing products and processes is really something that we're very focused on right now.”

So how exactly does compliance lead to quality? How are the two different, and how are they similar? I was given good, practical insights into how compliance and quality work together.

“In my experience, quality has typically been the what and the how,” says my contact. “It’s how you do something or how something needs to be accomplished or achieved—a quality system, really. It can be a real enabler to profit your cycle times depending on what type of product you're manufacturing. We have one therapy that is an autologous product. In that instance, developing quality systems that enable quick cycle times is important because we don't have the luxury of, say, a 90-day batch record review and release process with that type of product. You need a very specific quality system enabler to handle a more rapid cycle.

“Compliance, on the other hand, is really educating the organization on why we do the things we do. It’s about managing the best way to achieve a quality product. From a compliance perspective, the FDA is looking to see that we can provide a product that is safe, of a high quality, and of a high purity and potency. Ultimately, the quality systems and processes that we have in place are those that allow us to comply with those requirements from the FDA. So that's where I see the differences, and the overlap, between quality and compliance.”

The role of regulators

The FDA carries a somewhat menacing reputation that, in a sense, is well earned. FDA agents do carry badges and guns, along with the power to bring financial ruin to companies and significant legal jeopardy to executives and managers (see sidebar).

Of course, all this is necessary because the most important role of that administration is to protect us, the consumers of food, drink, pharmaceuticals, and medical devices made or sold in the United States. What’s sometimes less understood is the fact that the FDA protects life science manufacturers, too. Without this necessary oversight, and the framework of internal excellence it demands, companies in this space would not be as successful as they are.

Again, my contact provided an interesting perspective: “The FDA is ultimately responsible to consumers to ensure the safety and effectiveness of products. They also really collaborate very well with industry because they want us to be successful. At the end of the day, shutting down a facility that may be a single-source manufacturer for a chemotherapy drug might not be in the best interests of the American people, and so the FDA works very closely with industry.”

Warning letters and consent decrees are issued if significant flaws are discovered in a company’s quality processes, and those actions are serious indeed. But the vastly more significant step of shutting down production is rarer. Being mindful that direct dangers to the health and safety of the public are always given utmost priority, short of those actual threats, the FDA is generally more collaborative than adversarial in nature.

“The FDA wants to help manufacturers better understand how to have robust manufacturing processes and robust quality systems that achieve the goal of compliance but also are sustainable,” says my contact. “When it comes to questions like, ‘How do you really get product from the clinical realm into the commercial space?’ there is a collaboration that happens between a manufacturer’s regulatory team and the FDA. I see the FDA as helping to ensure that we're doing what we need to do and that they are offering guidance, in a very transparent way, so that we can be successful.”

Making it work

If quality is the “what” and the “how,” and compliance is the “why,” then the bigger questions are where the hand-off between the two occurs and when you know you’re doing it right.

There are no silver bullets or secret ingredients to quality or compliance, especially within this sector; there is only hard work, persistence, and the commitment to one’s customers to provide therapies that function safely and effectively.

To make compliance work as a driver of world-class quality, a manufacturer of life science products must be willing and able to understand the goal before constructing a framework to achieve that goal. And, tempting as it may be to consider the goal as only the approval of a given drug or therapy, it’s broader than that. The overarching ambition is to create a quality management system that all key players in the organization can draw from and contribute to. Such a system should be easily understandable and yield powerful, specific insights into the reasons for successful outputs. Do it right, and compliance to regulatory requirements is only the first of several significant benefits. Everything else—great public relations, growing market share, and blossoming shareholder value—will naturally follow as a function of outstanding quality.

“I don't want to be simplistic because it isn't simple,” this manager concludes. “But you start by taking a very methodical approach to the basic compliance requirements, and then you work through those processes and gain a better understanding of how they work in your organization, and how they complement your manufacturing processes. That just takes time and practice. You can build any kind of model conceptually until you actually walk through it. Sometimes you learn from failure, but that's not something that anybody is ever necessarily eager to take on. We don’t want to fail. We want to be successful.”