In the past three decades, an increasingly globalized medical marketplace has helped improve patient access to new medicines. Sadly, it has also provided an opportunity for more substandard, adulterated, and counterfeit medical products. This article explains the evolving role of the ICH in helping to tackle this problem through harmonization, and how USP is linked to the effort.
Today, approximately 80% of all active pharmaceutical ingredients in medicines sold in the U.S. are manufactured in another part of the world. While manufacturers have to ensure the quality and consistency of ingredients that go into final pharmaceutical products, they must also employ measures for the proper control of unwanted impurities in drugs and drug ingredients.