Navigation Links
Dietary supplements manufacturers gain new tool to help ensure quality products
Date:7/7/2009

Rockville, Md., July 7, 2009 A first-of-its kind collection of standards designed to assist dietary supplements manufacturers in providing quality products to consumers is being released today by the U.S. Pharmacopeial (USP) Convention. The USP Dietary Supplements Compendium (DSC) will also help manufacturers in complying with Food and Drug Administration (FDA)-issued current Good Manufacturing Practices (cGMPs). Under these practices, manufacturers are responsible for the quality of the ingredients they use in manufacturing their finished dietary supplements.

The DSC is a comprehensive resource containing quality specifications for dietary supplements and their ingredients. These quality specifications include standards for identity, strength, purity and performance characteristics (e.g., dissolution, disintegration) of more than 500 dietary supplements and ingredients. In addition to these standards, the DSC includes general and regulatory information, guidance documents, appendices, and macro/microscopy, thin layer chromatography (TLC) and high performance liquid chromatography (HPLC) full-color images that greatly simplify the analysis of ingredients of botanical originmaking it a central repository of necessary information for dietary supplements manufacturers.

"With the release of this new Dietary Supplements Compendium, USP is seeking to partner with ingredient suppliers, dietary supplements manufacturers, contract laboratories, regulatory bodies and independent consultants to raise the quality of supplements and to fulfill the need for public standards in the dietary supplement community," said James Griffiths, Ph.D., vice president of food, dietary supplement and excipient standards for USP. "With the current cGMPs from FDA stipulating that dietary supplements manufacturers determine the quality of ingredients they buy from suppliers by setting their own specifications, the DSC can significantly assist manufacturers by providing guidance on suitable specifications, including scientifically valid analytical methods and acceptance criteria. Consumers expect and deserve this kind of added protection."

The DSC serves as a tool for manufactures in:

  • Developing, manufacturing and testing new products;
  • Qualifying raw materials;
  • Preparing for international quality control and cGMP audits;
  • Setting and validating standard operating procedures;
  • Collecting in-process and batch-release tests; and
  • Accurately packaging, labeling and storing products.

The DSC draws its quality specifications from the United States PharmacopeiaNational Formulary (USPNF) and the Food Chemicals Codex (FCC), USP's publications of standards for the identity, strength, purity and consistency of medicines and food ingredients, respectively. These specifications include items that may be considered dietary supplements or ingredients, including amino acids, vitamins, minerals, articles of botanical origin and their dosage forms. USPNF is considered an official compendium under the Federal Food, Drug, and Cosmetic Act (FDCA), with the FDCA food misbranding provisions applying to any dietary supplement product represented as conforming to compendial specifications (and such products being deemed misbranded by FDA if they fail to so conform). USP has been setting quality standards for medicines for nearly 200 years.


'/>"/>

Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

Related biology news :

1. UF scientists reveal how dietary restriction cleans cells
2. Dietary calcium could possibly prevent the spread of breast cancer to bone
3. Changing the global dietary environment
4. Market testing of dietary supplements and drugs underscores value of USPs public health programs
5. Researchers uncover details about how dietary restriction slows down aging
6. The dietary supplement genistein can undermine breast cancer treatment
7. Annual Bibliography of Significant Advances in Dietary Supplement Research 2007
8. Results of the third school nutrition dietary assessment study published
9. Desert woodrats switch one dietary poison for another
10. Desert woodrats switch one dietary poison for another
11. Following the dietary guidelines may slow heart disease in women
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... Research and Markets has announced the addition ... - Industry Forecast to 2025" report to their offering. ... The Global Vehicle ... around 8.8% over the next decade to reach approximately $14.21 billion ... estimates and forecasts for all the given segments on global as ...
(Date:3/20/2017)... At this year,s CeBIT Chancellor Dr. Angela ... The Chancellor came to the DERMALOG stand together with the Japanese Prime ... partner country. At the largest German biometrics company the two government leaders ... iris recognition as well as DERMALOG´s multi-biometrics system.   ... ...
(Date:3/9/2017)... Australia , March 9, 2017 /PRNewswire/ ... at the prestigious World Lung Imaging Workshop at the ... Fouras , was invited to deliver the latest data ... This globally recognised event brings together leaders at the ... latest developments in lung imaging. "The ...
Breaking Biology News(10 mins):
(Date:4/28/2017)... ... April 28, 2017 , ... ... (CRO) has validated a 0.2 ng/mL lower limit (LLOQ) assay for nicotine and ... ng/mL LLOQ assay, the ultra-low trace nicotine assay meets additional needs of tobacco ...
(Date:4/27/2017)... SEATTLE, WA (PRWEB) , ... April 27, 2017 ... ... a revolutionary, cloud-based and secure electronic informed consent (eConsent) solution that simplifies research ... the technology and consulting division of Quorum, Q Consent™ is the first ...
(Date:4/27/2017)... Washington, USA (PRWEB) , ... April 27, 2017 ... ... for optics and photonics , joined other scientists, researchers, engineers, and industry professionals ... measures to strengthen America's ability to compete in the world photonics industry. , ...
(Date:4/26/2017)... ... 26, 2017 , ... WonderWorks, Myrtle Beach’s science focused amusement ... of deep space exploration and inspire space enthusiasts. The exhibit features interactive exhibits ... guest appearance by former Shuttle Astronaut Don Thomas. , The intergalactic weekend kicks ...
Breaking Biology Technology: