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Healthy INSIDER Podcast 87: FDA's Thinking on Supplement GMPsHealthy INSIDER Podcast 87: FDA's Thinking on 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 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

editor in chief, Informa

Sandy Almendarez entered the natural products industry in 2009 when she joined Virgo Publishing (now Informa Exhibitions) as an assistant editor. Since then, she's worked her way up to editor in chief where she writes, edits and manages content for INSIDER. Under Sandy’s direction, INSIDER has won editorial awards from Folio: every year since 2014, including B2B Editorial Team of the Year in 2015.

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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