Regardless of whether it’s prescription or over-the-counter, the ingredients on a drug product label typically include one, maybe two, active pharmaceutical ingredients (APIs). The rest of the list is comprised of “inactive” ingredients (excipients) which in reality are far from inactive. Variability may be acceptable for products such as printer ink and paintballs, but not pharmaceuticals, making quality standards for excipients critical to ensuring consistent drug quality.
USP was founded nearly 200 years ago by eleven doctors who wanted to ensure that the nation had access to quality medicines. They put together the first pharmacopeia, a book of recipes for making tinctures, extracts, and other medicines.
Building the marketplace for generic medicines is a key strategy to containing drug costs in the US, one that USP actively supports through our standards-setting work.
Establishing the suitability of packaging systems for pharmaceutical products is critical. With many new materials and applications entering the marketplace, testing procedures for these systems need to be revised regularly to make sure quality attributes are considered. To that end, USP has started an effort to modernize its packaging standards. Learn more.
As more drug makers adopt pharmaceutical continuous manufacturing, new technological developments and operational demands are resulting from new partnerships among academic centers and industry leaders, particularly in the past two years. To this goal, USP recently formalized collaborations with Center for Structured Organic Particulate Systems (C-SOPS), a leader in research on PCM. Learn more about the opportunities in this field.
USP releases draft Medicare Model Guidelines version 7.0. Read and comment between now and November 2, 2016.
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.
Dr. Maya Guncheva, a USP visiting scientist from Institute of Organic Chemistry, Centre of Phytochemistry at the Bulgarian Academy of Sciences provides a brief account of her research interests, what brought her from Bulgaria to Rockville, and the highlights of her experience at USP.
In LMICs, the availability of medicines manufactured locally that do not meet quality standards is a leading cause of treatment failure and adverse events in patients and is undermining public health interventions. But where do things go wrong during pharmaceutical manufacturing in LMICs that give rise to this problem? Learn more.