FDA's Global Initiative; FDA Across the Globe

Global Initiative

Global production of FDA-regulated products has quadrupled over the last decade and continues to grow.  Today, FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities.

Almost 40 percent of the fruits and nuts and 85 percent of the seafood consumed in America comes from abroad.  Similarly, more than 80 percent of the active pharmaceutical ingredients used to make medicines are imported. The growth in imports has been rapid and promises to accelerate.

Globalization has fundamentally altered the economic and security landscape and demands a major change in the way FDA fulfills its mission.  Over the next decade, FDA will transform from a predominantly domestically-focused agency operating in a globalized economy to a modern public health regulatory agency fully prepared for a complex globalized regulatory environment.

The agency is already working to increase transparency and accountability in the supply chain, developing better enforcement and regulatory tools, encouraging greater responsibility by industry, and enhancing collaboration with international regulatory counterparts and other third parties.

As our world transforms and becomes increasingly globalized, it is vital that we come together as a global community – in new, unprecedented, and even unexpected ways – to build a public health safety net for consumers around the world.
 

• More information on Global Operations

FDA has established international offices and posted staff in strategic locations around the world. They work closely with their national and regional regulatory counterparts, and with other U.S. government agencies stationed abroad, to perform functions essential to FDA’s ability to protect U.S. consumers. Learn more about FDA’s international offices and posts.

This article found on FDA;s website here.

FDA Warning Letters for International APIs in 2011

The following blog post can be found here.

FDA Warning Letters for International APIs in 2011

January 8, 2012

FDA issued at least ten Warning Letters to international manufacturers of active pharmaceutical ingredients in FY-2011. Manufacturers in both China and India, the world’s largest exporters of APIs, received three Warning Letters each from FDA. Manufacturers in Spain, the UK, Canada, and Japan each received one Warning Letter from FDA. These metrics show both the domination of China and India in the API market as well as the continued dependence on international manufacturers for APIs destined for the U.S. market.
Deficiency Categories:
The violation that dominated the charges cited by FDA in FY-2011 related to quality control, cited in four Warning Letters, two to China and one each to Canada and Japan.
Another violation that is sure to cause concern with FDA is the failure to prevent cross-contamination. When I attended FDA API inspection training in 2000 cross-contamination, particularly with anti-biotics, was a major concern. It continues to be with API manufacturers in both India and China being cited for the “Failure to have appropriate procedures in place to prevent cross-contamination.”
Out of specification (OOS) laboratory results are always a concern of FDA and landed on Warning Letters to manufacturers in India and Spain. Other citations include:
= Water purification for APIs used in parenterals
= Failure to establish a stability program to monitor APIs
= Failure to perform at least one identity test of each batch of incoming material
= Validation of analytical methods used to test APIs
There are no big surprises here but it shows that regular surveillance of API vendors is an absolute necessity for the manufacture of quality drug products. What is of interest is that GxP Perspectives couldn’t find any domestic Warning Letters for APIs. That doesn’t mean they don’t exist, only that they couldn’t be easily located. Unfortunately, FDA lists API Warning Letters in any number of classifications for GMPs for finished pharmaceuticals. However, they don’t seem to list them for APIs. With all the razzle-dazzle taking place on FDA’s website, you would think they could come up with a consistent way to list API Warning Letters. Who knows, maybe next year.
by Carl Anderson, GxP Perspectives
Research by Francesca Carreras-Perez, GxP Perspectives
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