Quality at USP
Quality plays a role in everything we do at USP. It’s befitting that this month—which is World Quality Month—we are writing on the topic of “quality”.
If you’re familiar with our organization, you probably already know that we create quality standards for drug substances, drug products and their ingredients. You’re probably also aware that these standards are published in the United States Pharmacopeia—National Formulary (USP–NF) and often include reference standards—very pure physical samples used as reference chemicals—applied as comparison standards when testing for product quality.
However, USP’s efforts related to quality span a wide range of other products and programs. In the spirit of World Quality Month, here are some other USP activities that you may not know about.
Since 2006, USP has developed standards for the Food Chemicals Codex (FCC), a compilation of food ingredient standards that serves as something of a “dictionary” in which minimum quality specifications are described in detail. FCC standards are widely used in commerce, and regulators can also make use of the FCC where specifications for food ingredients play a role; for example, over 200 FCC standards have been incorporated by reference in U.S. Food and Drug Administration food regulations.
Through the FCC, USP helps manufacturers and suppliers to “speak the same language” when procuring their ingredients by providing food ingredient standards. This is particularly important given the global nature of today’s food supply chain.
In the area of food integrity, USP also maintains the Food Fraud Database—a source of information for industry as well as regulators to help identify food ingredients that are vulnerable to adulteration as well as possible adulterants, themselves. Recognizing that it is hard to get all information on food adulteration from a unique source, USP has compiled this database of reported cases of food fraud found in scholarly articles and media reports.
Dietary supplements use has become so popular in the U.S. that many consumers are complacent when it comes to their quality and safety.
It is important to understand, however, that supplements are regulated in the U.S. essentially as foods and not like drugs. Clinical and other research studies are not required and the rigor of studies reported in the media is of uncertain value.
Most quality specifications for dietary supplements in the United States are set by manufacturers with no premarketing oversight and few uniform requirements. For that reason, the quality of dietary supplements may vary significantly from one manufacturer to another.
USP–NF has a special section containing public standards for dietary supplements and so does USP’s Dietary Supplements Compendium, with added information. Manufacturers seriously concerned with providing their consumers quality products can use and claim USP standards on their labels, so consumers can better distinguish those companies most committed to ensuring quality.
Some manufacturers take an extra step and use USP verification services, which indicates not only the manufacturer’s good intentions, but also that USP, as an independent non-profit organization, has audited their facilities, reviewed quality documentation and tested their products. In this way, consumers that look for the USP Verified mark on the dietary supplements they purchase can be more confident about their quality.
Packaging, Storage and Distribution
While the quality of final products and ingredients is a central focus for USP, packaging, storage and distribution also can play critical roles when it comes to quality. As the manufacture of medicines, food ingredients and dietary supplements continues on a global path, being able to control and maintain robust systems that support product quality is equally important.
USP’s activities related to packaging and distribution include the quality of materials used in container closure systems, particulate matter associated with injectable drug products and good distribution practices that support supply chain integrity.
Quality Plays a Role in Everything We Do
If you’re interested in learning more about USP’s standards-setting activities related to medicines—as well as food ingredients, dietary supplements and product packaging and distribution—follow us on USP’s blog, “Quality Matters”. We’re also active on Facebook, Twitter and LinkedIn. We’d like to hear from you!