Trade groups unite to produce CoA guideline

By Shane Starling

- Last updated on GMT

Related tags: Food and drug administration, Dietary supplement

Five major dietary supplement trade associations have published Certificate of Analysis (CoA) guidance to help suppliers meet GMP requirements after several collaborating on the project.

The guidance adds to Food and Drug Administration (FDA) CoA guidance that exists in the Good Manufacturing Practices (GMP) rule, with an emphasis on greater detail and user-friendliness for finished product manufacturers.

The Joint Standardized Information on Dietary Supplement Ingredients (SIDI) Working Group has been working on such guidance since 2005, said Dan Fabricant, PhD, the NPA’s vice president of scientific and global government affairs.

Plug and play

He said any CoA ‘data holes’ that had become apparent from FDA 483 inspection reports were pure coincidence, as the work was mostly completed before the 483 reports started rolling in. But two FDA GMP experts – Carl Reynolds and Brad Williams – consulted with the five trade groups to produce the document.

“No matter how sophisticated companies become there will always be a need for this kind of ‘plug-and-play’ guidance,​” Fabricant said. “What this does is make it easier to qualify ingredient suppliers and can be used by all in industry from the smallest to the biggest companies.

The five groups are the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA).

The document which relates to both botanical and non-botanical substances – can be found on the web sites of all five associations along with original SIDI protocol materials.

A requirement of the supplier qualification process involves verifying the information provided in an ingredient CoA, and manufacturers of dietary supplements rely on supplier CoAs to ensure finished products are GMP-compliant,”​ said Andrew Shao, PhD, a spokesperson for the SIDI Working Group and CRN’s senior vice president of scientific and regulatory affairs.

“It’s essential for ingredient suppliers to have a form that can be consistently used, containing the appropriate information in a clear and concise format. By standardizing the information on CoAs, this voluntary guideline will benefit both ingredient suppliers and dietary supplement manufacturers.”

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