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IDDI™ Verifications address key parts of Good Manufacturing Practices (GMP)

IDDI Verifications Improve GMP Compliance

GMP's are required for dietary supplements and other natural products consumed by people.  GMP audits typically include more than 200 different checks, and include a brief review of identity, specifications and supplier qualification, IDDI™ Verification goes far beyond the typical GMP audit, and includes a review of test methods and results to evaluate scientific validity -- the FDA requirement.

The recent actions by the NY Attorney General

 has added to the mass confusion on how to properly identify ingredients and qualify products and suppliers under dietary supplement GMP.  

Even before the recent media, natural products scientists, industry stakeholders, and standards-setting organizations have spoken at length about the need for straightforward, universal standards for identity testing.

Although there is no 'one-size-fits-all' test method or litmus test for identity, specifications and supplier qualification, IDDI™ Verifications seek to clarify the confusion by charting universal standards and provide a clear path for clients to improve the compliance and confidence in the integrity of their ingredients.

A Note on ID: When is an apple not an apple?

If an apple is clearly an apple, then why does identification pose such challenges? Due to today's global supply chains, dietary ingredients materials are generally processed into powders or liquids - forms that can no longer be identified by sight or smell.  Since FDA requires the end manufacturer to identify dietary ingredients through testing, botanical identity tests using authentic voucher standards or chemical tests using technologies like chromatography are critical for identification.  Also, since each ingredient has its own unique supply chain, appearance and chemistry, identity tests for each ingredient often need to be tailored and specific, and compared to authentic references to confirm identity. A crab apple is very closely related to a "Red Delicious", although only one of these is preferred for eating -- so it is critical to be able to tell the difference.

The IDDI Process

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