The Role of Standards in Sustainability

For pharmaceutical manufacturing professionals, sustainability is increasingly defined by the intersection of operational efficiency, digital transformation, and global regulatory alignment. Tony Lakavage, executive vice president and head of Global External Affairs at the US Pharmacopeia (USP), highlights how the drive for sustainability aims to reduce the industry's environmental footprint while simultaneously enhancing efficiency and reducing the consumption of natural resources.

How does sustainability fit factor into operational efficiency and Pharma 5.0?

A critical component of this transition is the shift toward Pharma 5.0, which involves the integration of digital systems for real-time quality improvement. These advanced systems allow for real-time adjustments to limit the use of natural resources and automated controls to deactivate equipment when it is not in use.They also enable identification of environmentally friendly solvents and modern technologies that may replace legacy processes.Beyond facility design, efficiency in quality testing is a primary lever for sustainability, as it allows companies to save money while using fewer resources.

What is the role of harmonized standards?

Global harmonization of standards is essential for environmental progress , according to Lakavage. If different countries maintain conflicting regulatory approaches, the industry's total environmental footprint may actually increase due to redundant or inefficient requirements.

Currently, USP standards are utilized in 22,000 manufacturing facilities across 140 countries. Because of this massive scale, even small updates to these standards—such as those coordinated with the European Pharmacopeia—can have an oversized impact on global sustainability.

How is the impact of sustainability measured?

While the innovator industry is already advanced in measuring progress regarding waste reduction and fuel consumption, USP is working to further support these metrics through updated standards. According to Lakavage, USP’s key objectives for the next five years include eliminating animal testing to modernize and humanize quality benchmarks , reducing the overall use of natural resources in laboratory and production settings , and finding safer, non-toxic chemical alternatives to replace hazardous materials.

By integrating these modern technologies and sustainable practices into the core pharmacopeial standards, the industry can ensure that environmental progress is both measurable and consistent across global supply chains

Transcript

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Good afternoon. I'm Tony Lakavage, and I am the Executive Vice President and Head of Global External Affairs at USP.

In what ways is the drive for sustainability influencing facility design, process selection, and sourcing strategies, and how are companies measuring environmental progress?

The drive for sustainability has multiple elements to it. What we all initially think is that it's about reducing the environmental footprint of pharma manufacturing, and that's true. That's definitely true. But it's also about greater efficiency and reducing the use of natural resources, for instance, finding more, more efficient ways to, in an area that is central to our work, quality testing, is something that saves industry money using fewer natural resources and also is good for the planet.

So, what we've seen is more, we've talked about Pharma 4.0, and now we're at Pharma 5.0, which is the integration of digital systems that not only are doing real-time, quality improvement, for instance, but they're also doing real-time, adjustments to limit the use of natural resources, to limit the use of equipment when it's not necessary. So that, that's pretty essential.

And we also see within facilities that industry is doing all kinds of things to ensure that they're minimizing waste, as a matter of fact, and using, more environmentally friendly solvents is another key area. Something that we're doing at USP and working with other pharmacopeias on now is to integrate modern technologies into USP standards as a way of helping to reduce the broader, environmental footprint of the industry.

And this is one area that it's essential to harmonize, because if we have different approaches in each country, that actually may increase the environmental footprint.

So, this is one of our key objectives over the next five years, that the USP convention passed a resolution on to help reduce the environmental footprint. That also means eliminating animals in testing, for instance, reducing the use of natural resources as well, finding alternative, chemicals to toxic ones. Environmentally friendly solvents are one area, but it's not the only one.

So, how do you measure the impact? I think there are a lot of ways to measure the impact, very, obvious ones about waste and the use of fuel in facilities. The pharma industry, in particular, the innovator industry, is pretty developed in measuring and showing progress, as a matter of fact, in their environmental impact.

And, that's something that we're working to support. The impact of USP standards is something that may not be intuitive at first when we think about the impact of standards on the environment or the environmental footprint of manufacturing, or even on, on public health. How can they have such a big impact?

And the truth is that USP standards are utilized in twenty-two thousand manufacturing facilities around the world that supply medicines to the United States and to other countries. And I say that because USP standards are utilized in a hundred and forty countries around the world.

When you add that to additional facilities that may be manufacturing to European Pharmacopeia standards, for instance, and others, you have a really significant impact.

And when we can work together for the convergence or harmonization of standards, that's even better. So, this is why we take our work very seriously. And on the environment, we think that making some changes to our standards is going to have a really important, oversized impact on the planet.