Article in Natural Products Insider Highlights How Supplement Companies Can Ensure Regulatory Compliance when Using Contract Manufacturing
Robert Danko, Of Counsel to the firm, was recently published in Natural Products Insider, addressing a number of issues facing supplement companies surrounding the use of contract manufacturers. As the use of contract manufacturers continues to rise, Robert highlighted important things that both supplement companies and independent contract manufacturers need to keep in mind when it comes to ensuring regulatory compliance – including the vital importance of ingredient testing to ensure all ingredients meet specifications.
Robert’s article, “Testing Ingredients and Components for Identity and Quality”, is published in the March 23rd edition, and addresses the key issues of ingredient testing, production/process control and retaining samples. In addressing what is required for ingredient testing in the supplement industry, Robert highlights the important differences between the testing of components, ingredients and dietary ingredients –pointing out the distinctions and different testing protocols for each. While noting that “all dietary ingredients must be tested or examined prior to use to verify identity”, Robert also points out an exception allowing companies to petition to FDA for an exemption to the testing requirement – noting, however, that petitioning will result in an alternative test, meaning that “for the vast majority of dietary ingredients, at least one test or examination must be conducted to verify its identity prior to use.”
The article offers a comprehensive overview of how supplement companies and contract manufacturers today can ensure compliance with 21 CFR 111 in a number of areas. In addition to ingredient testing, the article also discusses proper production and process control systems in dietary supplement manufacturing, as well as quality control procedures surrounding collecting, retaining and identifying samples (which include not only ingredients samples, but items such as bottles, caps, blister packs and product labels.)
As one of the country’s leading legal authorities in the area of GMP regulations and FDA compliance, Robert offers valuable, and timely, insight for both brand owners and supplement makers in this important article. To read Robert’s article, click here: http://www.naturalproductsinsider.com/articles/2016/03/testing-ingredients-and-components-for-identity-a.aspx. In addition, for more information about Mr. Danko and his leadership in helping companies and manufacturers prepare for FDA inspections and avoid potential GMP failure, call us at 516-294-0300 to learn more about how we can help your dietary supplement business ensure compliance to all current regulations.