March / April 2017

Compliance & Sustainability: Conflict or Harmony?

Norman A. Goldschmidt

When we discussed assembling this month’s special report on sustainability, the idea of pairing it with an issue on compliance challenges was not an obvious choice. Despite those initial misgivings, the reality is that these two topics are a superb pairing; the drive for both sustainability and harmonization of regulations illustrate the evolution of our industry from a mindset of unquestioning compliance to thoughtful stewardship of public trust.

Personally, the impediment I most often encounter when exploring issues of sustainability (say by optimizing cleanroom performance, challenging air change rates and velocities) is cultural and perceived regulatory inertia—that unquestioning compliance mindset.

Now I’m no fan of the term “sustainability”; it’s hard to muster any enthusiasm for staying in one place. Rather, let’s talk about increasing efficiency, eliminating waste and maturing our processes. Increasing efficiency is the natural function of engineers. Our job is to apply scientific understanding to real world problems, building solutions that are both cost-effective and of real benefit. “Lean” and “green” should be synonyms, not antonyms, and they should fit seamlessly with our mandate to assure the safety, purity, and quality of our products.

Assurance of quality flows naturally from a deep understanding of process and product. The better we understand what does and does not affect a product, the better we can control its quality. This insistence on rigor and challenging the status quo leads to an appreciation that there is no single design for all facilities. Contamination controls that are appropriate for one product may be inappropriate (or worse, ineffective) for another. With new breakthrough therapies, technologies, and processes developing seemingly every day, this understanding is more important than ever.

With cell and gene therapies utilizing viral vectors to transform the essential code of our DNA, continuous processing transforming the layout of our facilities, and closed single-use technologies transforming the very definition of what we call a pharmaceutical facility, this may be one of the most challenging and exciting periods in our history. It’s also the reason I am optimistic for ISPE’s opportunity to help bring about material change.

Seeking ways to refine and focus our efforts on the real drivers of product quality is perfectly natural for an organization of pharmaceutical engineers, scientists, and regulators who have dedicated their careers to the discovery and production of safe treatments to enhance and extend lives.

Some 15 years ago, in “Pharmaceutical cGMPs for the 21st Century” the FDA charged us to “… encourage implementation of risk-based approaches that focus both industry and agency attention on critical areas … based on state-of the-art pharmaceutical science.”

Now, a decade and a half later, we find ourselves in the middle of the transformation, our community wrestling with the very core of this mission: to understand the underlying issues that influence quality and address them consistently across the globe.

We do indeed live in interesting times, with change coming at us at an ever-increasing rate. But with change comes opportunity, and the opportunity to make safe products with lower environmental impact and cost has never been more promising.