The preamble to the dietary supplement cGMPs (current good manufacturing practices) is an often-overlooked resource that help businesses that manufacturer, package, label or hold supplements in the United States. As Dr. Tara Lin Couch, EAS independent advisor, dietary supplements, noted in this podcast with Sandy Almendarez, editor in chief, INSIDER, this preamble is FDA's guide to what it is thinking on specific GMP requirements. Couch and Almendarez further dive into supplement GMPs.

The preamble to the dietary supplement cGMPs (current good manufacturing practices) is an often-overlooked resource that help businesses that manufacturer, package, label or hold supplements in the United States. As Dr. Tara Lin Couch, EAS independent advisor, dietary supplements, noted in this podcast with Sandy Almendarez, editor in chief, INSIDER, this preamble is FDA’s guide to what it’s thinking on specific GMP requirements. Couch and Almendarez further dive into supplement GMPs and cover:

  • Why the last, shortest subpart of the GMPs (CFR 111, subpart P) is the most important

  • How often supplement brands should audit their contract manufacturers

  • Other regulations supplement brands need to consider in developing their manufacturing standard operating procedures (SOPs)

Hear more insights from Tara Lin Couch and other experts at the SupplySide West Workshop, “Selecting and Testing Your Contract Laboratory, on Tuesday, Sept. 26 at 9 a.m. Visit supplysideshow.com for more information and to get registered.

About the Author(s)

Sandy Almendarez

VP of Content, Informa

Summary

• Well-known subject matter expert within the health & nutrition industry with more than 15 years’ experience reporting on natural products.

• She cares a lot about how healthy products are made, where their ingredients are sourced and how they affect human health.

• She knows that it’s the people behind the businesses — their motivations, feelings and emotions — drive industry growth, so that’s where she looks for content opportunities.

Sandy Almendarez is VP of Content for SupplySide and an award-winning journalist. She oversees the editorial and content marketing teams for the B2B media brands Natural Products Insider and Food and Beverage Insider, the education programming for the health and nutrition trade shows SupplySide East and SupplySide West, and community engagement across the SupplySide portfolio. She is a seasoned content strategist with a passion for health, good nutrition, sustainability and inclusion. With over 15 years of experience in the health and nutrition industry, Sandy brings a wealth of knowledge to her role as a content-focused business leader. With specialization in topics ranging from product development to content engagement, creative marketing and c-suite decision making, her work is known for its engaging style and its relevance for business leaders in the health and nutrition industry.

In her free time, Sandy loves running, drinking hot tea and watching her two kids grow up. She brews her own “Sandbucha” homemade kombucha; she’s happy to share if you’re ever in Phoenix!

Awards:

Speaker credentials

Resides in

  • Phoenix, AZ

Education

  • Arizona State University

Contact:

Tara Couch

Tara Lin Couch, Ph.D., owner of TLC Regulatory and Laboratory Consulting, is an analytical/organic chemist who also obtained a bachelor’s degree in mathematics. She has more than 35 years of diverse laboratory and regulatory experience in academic, field, contract and manufacturing environments. Couch is a sought-after expert on issues pertaining to quality control in pharmaceutical, dietary supplement, tobacco manufacturing and the cannabis industries. As a consultant, she assists with the development, improvement and implementation of quality systems that are scientifically sound, efficient, practical and compliant with FDA regulations.

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