Anita Szajek, Ph.D., principal scientific liaison to USP’s Expert Panel on Therapeutic Peptides, examines therapeutic peptides, the transition from recombinant to synthetic manufacturing routes, and regulatory and quality-related questions.
In conversations about the role of quality standards in public health, you might come across the words “compendia” and “compendial.” At USP, terms like “compendial approaches,” “compendial standards,” and “compendial tools” are part of our everyday vocabulary.
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.
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.
Margaret Hamburg is approaching the end of a successful six-year tenure as Commissioner of the U.S. Food and Drug Administration. USP extends its congratulations to Dr. Hamburg in this letter from CEO Ron Piervincenzi.
Tuberculosis (TB) is one of the world’s most prevalent diseases – it kills three people every minute. Although progress has been made in expanding access to treatment, the rate of multi-drug resistant TB cases has nearly doubled between 2011 and 2012. One factor driving drug resistance is poor quality drugs. Several global health organizations have partnered together to find a solution to ensure that safe and effective medicines are used in their treatment programs.
What are medicine impurities and from where do they come? Identifying and describing impurities is a critical safety issue concerning manufacturers, regulators, and patients. This post describes the types of impurities found in medicines and how they may impact drug quality.