Learn about and view the new suite of physical and written standards that USP is developing to help biologics manufacturers develop and analyze therapeutic proteins. New general chapters address analytical procedures for monoclonal antibodies, oligosaccharides, and protein determination.
Thank you for helping Quality Matters spread the word in 2015 about USP quality standards and the important role our work plays in industry, public health and lives around the world. These five posts are the ones that you, our readers, found to be the most engaging and useful in 2015.
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.
The USP Verified Mark and the Good Housekeeping Seal help consumers find quality products in the marketplace. But did you know these two seals enjoy a shared history? Each is the legacy of the work of pioneering consumer activist and “Father of the Pure Food and Drug Act”—Harvey W. Wiley, M.D.
Patrick Lukulay, USP’s VP of GHIP–Africa, discusses plans to leverage his new post in Accra, Ghana to advance pharmaceutical quality in Africa. Countering fallacies in drug quality through advocacy and working to help build an enabling environment that can sustain systems for effective regulation of medical products, he says, are needed for this to happen.
Almost half of the world’s population is at risk of malaria. Malaria Day in the Americas celebrates progress made to prevent, detect, treat and defeat malaria in this region. Learn how Promoting the Quality of Medicines (PQM) is helping by increasing the availability of quality-assured antimalarials.