• 17 Jan 2013 9:00 AM | Anonymous
    The SIDI Work Group releases a new voluntary guideline, the Dietary Supplement Component Supplier Qualification, to help the dietary supplement industry meet cGMP requirements. Find out more...
  • 20 Aug 2012 12:44 PM | Anonymous



    Raw Material Documentation and GMP Compliance
    With the implementation of the Food Safety and Modernization Act, the dietary supplement industry must place greater emphasis on increasing traceability of the supply chain to ensure the manufacture of quality products and the prevention of economically motivated adulteration. Failure in creating and keeping appropriate documentation is one of the common GMP deficiencies flagged by FDA 483s and warning letters. Key to knowing your product, from “seed to shelf,” is the assessment of raw materials intended to be manufactured into finished products. This process involves retrieval, review and approval of important documentation related to the raw material, including specification sheets, certificates of analysis, identity tests, GMO labeling statements and manufacturing information. The efficiency of the documentation process contributes to resource savings as well as confidence in the safety and quality of finished products.
  • 17 Apr 2012 4:35 PM | Anonymous

    SIDI Work Group’s Draft Dietary Supplement Component Qualification Guideline is open for comment until June 18, 2012.  More details here...

  • 07 Mar 2012 3:34 PM | Anonymous
    The draft of the Voluntary Component Supplier Qualification Guideline is coming soon. There will be an open comment period for interested persons to submit comments on the draft to the SIDI Work Group.

DISCLAIMER: These voluntary Guidelines are for information purposes only and intended to assist users with compliance with the cGMPs for Dietary Supplements, 21 C.F.R. § 111. The Guidelines should not be utilized as a substitute for compliance with all applicable laws and regulations. The Authors make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, or suitability of the Guidelines for any purpose. By use of these resources, the user agrees not to hold the authors liable or responsible for the user’s compliance with all applicable laws and regulations. CLICK HERE TO READ FULL DISCLAIMER.

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