SupplySide West Podcast 9: GMP Compliance for Supplement Manufacturers

GMPs (good manufacturing practices) are critical for meeting safety and legal requirements for dietary supplements made in the United States, yet, FDA still finds most firms aren't meeting all of the obligations. Per FDA audits, the most common violations include lack of specifications, not verifying suppliers, and incomplete master manufacturing records (MMRs). However, brands that carefully review their standard operating procedures (SOPs) can help ensure they meet all the requirements.

Sandy Almendarez, VP of Content

August 16, 2016

GMPs (good manufacturing practices) are critical for meeting safety and legal requirements for dietary supplements made in the United States, yet, FDA still finds most firms aren’t meeting all of the obligations. Per FDA audits, the most common violations include lack of specifications, not verifying suppliers, and incomplete master manufacturing records (MMRs). However, brands that carefully review their standard operating procedures (SOPs) can help ensure they meet all the requirements.

In this episode, Joy A. Joseph, chief operations officer, Joys Quality Management Systems, and Sandy Almendarez, editor in chief, INSIDER discuss:

  • The importance of establish product specifications

  • The information that needs to be included in MMRs and batch production records (BPRs)

  • FSMA’s preventative controls and how they affect manufacturing of dietary supplements

Joseph will be speaking on GMP Compliance for Supplement Manufacturers at SupplySide West as part of the Workshop: Contract Manufacturing: Raising the Bar on Delivering Quality on Saturday, Oct. 8 at 8:30 a.m. Visit supplysideshow.com for more information and get registered. This session is underwritten by Paragon Labs, National Enzyme Co., Bio-Energy Systems and BASF, the official education sponsor of SupplySide West.

Links and Resources:

About the Author

Sandy Almendarez

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 SupplySide Supplement Journal and SupplySide Food & Beverage Journal, the education programming for the health and nutrition trade shows SupplySide Connect New Jersey and SupplySide West, the education program SupplySide Fresh for industry newcomers 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:

See more from Sandy Almendarez
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