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.
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.
Desmond Hunt, Ph.D., USP’s Senior Scientific Liaison, provides insight into metal packaging systems for drugs and how USP standards can support quality in this field. Dr. Hunt works closely with USP’s Expert Committee on Packaging and Distribution—the volunteer experts who serve as key decision-makers in the USP standards-setting process. Learn more.
Over-the-counter (OTC) medicines, drugs available to consumers/patients without a prescription, play an important role in our modern healthcare system. An upcoming Consumer Healthcare Products Association workshop highlights how USP collaborates with key stakeholders to help address specific needs in OTC manufacturing and testing related to drug quality. Learn more.
Learn what the letters “USP” mean on medicine labels, the origin behind them, and how they are related to U.S. laws that aim to protect medicine and dietary supplement quality.
Learn about USP’s comprehensive approaches for updating three high-priority excipient monographs—Guar Gum, Shellac, and Butylated Hydroxytoluene—the challenges encountered, and progress made implementing an initiative to develop up-to-date USP–NF excipient monographs.
Pharmacopeial Forum (PF) is the vehicle through which USP publishes proposed revisions to USP–NF standards for public review and comment. Learn about PF and how you can use it to help shape standards for drugs, excipients and dietary supplements.
Dissolution, disintegration and drug release tests are important tools during the entire lifecycle of a drug product, from early development throughout its shelf life. USP’s Margareth Marques, Ph.D., provides answers to common questions and insight into standards and resources for these tests.