Attending SupplySide West in November? Come hear about raw material documentation in the context of supplier qualification and GMP compliance at SupplySide West Education!

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.

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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