Almost 200 years ago, 11 physicians recognized an essential need for consistency and quality regarding medicines and came together to create the United States Pharmacopeia (USP). Since then, USP's focus on quality has expanded to new areas in medicine, pharmacy, dietary supplements, and foods. From quality-related science and research, to field work and consumer tips, our hope is to address a universe of issues – all linked together by a common theme, that the quality of these items has a profound impact on our lives.
One common question that we hear is, what is a Pharmacopeial Monograph? It's a great question. Monograph development is a complex activity requiring participation from academia, the pharmaceutical industry, government agencies, and USP’s expert committees. In this article, learn the key steps in developing a monograph and where all these disciplines fit in the process.
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.