Ensuring Drug Quality: A Complex Task in a Globalized Era - Pharmaceutical Executive


Ensuring Drug Quality: A Complex Task in a Globalized Era

Pharmaceutical Executive

Moving Beyond Borders

While USP standards are recognized in law in the United States, they are used today in more than 130 countries—not only for compliance with US law in the course of exporting FDA-approved articles to the US, but also for local use and elsewhere. As such, USP's approach to its work has evolved. The organization has established several international offices and laboratories—first in Switzerland (2005), followed by full-service laboratory sites in India (2006), China (2007), and Brazil (2008). FDA has now opened offices in several of these countries, or in nearby ones—and USP collaborates closely with the agency in those and other nations in which we are operating. More than half of USP's reference material sales (a key indicator of who is utilizing our standards) now come from overseas—and it is essential to have a presence in areas in which our standards are being used.

In addition to its global sites, USP has forged international agreements with governments, industry associations, and others around the world. Primarily achieved through a Memoranda of Understanding, USP is now engaging in exciting projects such as joint standards development with China and India as well as scientific exchange programs. USP has also entered into adopt-adapt agreements with countries including Kazakhstan and Ukraine that will allow them to use USP's written standards in their own publications, either by including them entirely as they are published in the USP–NF, in translation ("adopted"), or modified to better suit the country's requirements ("adapted"). Furthermore, USP has made a concerted effort to include international experts on its Expert Committees, which are responsible for making scientific and standards-setting decisions for the organization. Currently, 23 percent are from countries outside the United States. Finally, USP operates several different verification programs—for finished dietary supplement products, dietary supplement ingredients, and pharmaceutical ingredients (active pharmaceutical ingredients and excipients)—in which companies enlist our services to verify the quality and consistency of materials. The rigorous programs, which involve document reviews, GMP audits, extensive laboratory testing, and continued monitoring and surveillance, are an additional way for companies to ensure the quality of ingredients and products. Participants in these programs come from around the world.

The Role of Industry

In all of our work, industry plays an essential role—and USP and industry have partnered closely for many years. Where our collaboration is absolutely critical is in standards development. As we work to modernize our standards—particularly those we've identified as priorities—we are looking to strengthen our relationship with industry further. We hope to have manufacturer support through increased submissions of modernization proposals to USP. Further, public review of any modernization proposal will be another important way we will look to collaborate with industry. All proposals will be included in the Pharmacopeial Forum (PF), the vehicle in which USP solicits public feedback on its standards. Changes to these standards will potentially affect the industry significantly, and participation will allow manufacturers to apply their insight in helping to assure the compendium is based on the latest sound science, and to avoid any unnecessary problems or burdens related to compliance. To help ensure greater participation in the standards-setting process, USP is transitioning PF to a free resource beginning this month.

Through these activities and many others, USP shares the pharmaceutical industry's goal of contributing to a safe, high-quality supply of medicines. While today's realities have necessitated changes in our approach, we are eager to meet the challenge, because our public health motivations are the same as they were in 1820. We believe the initiatives we are pursuing to modernize our standards will better serve the public, as well as the regulatory community and industry. Industry involvement is critical for achieving our shared public health goals.

Roger L. Williams, MD, is the chief executive officer of the US Pharmacopeial Convention


blog comments powered by Disqus

Source: Pharmaceutical Executive,
Click here