 Mollie Kober DBA Analytical/NSF International Consultant Visit Website |
Ms. Kober is a consultant in the dietary supplement and food industries. She has worked with numerous companies world wide providing expertise in GMP implementation, facility design and supply chain management. Ms. Kober has consulted with NSF since 2005, auditing over 75 companies in Europe, Japan, Canada and the U.S. In addition to auditing, Ms. Kober provided much of the content for the dietary supplement Guidance Document and reviews corrective action responses for GMP audits. Prior to consulting, Ms. Kober worked as the supply chain manager for a Chinese supplement distributor and manufacturer. She has visited numerous manufacturing facilities in China. Ms. Kober began her career with Cargill where she worked as an engineer constructing and operating a Chondroitin Sulfate factory. Ms. Kober received a B.S. degree in Chemical Engineering from Montana State University, is married with two children and currently resides in Denver CO. |
Good Manufacturing Practices Q&A
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What tests would need to be performed on a vitamin and mineral premix that is going to be put into a powdered nutritional beverage supplement? If the mix contains 20 different vitamins and minerals, does the manufacturer have to test the mix for the identity of each of the 20 nutrients? If the manufacturer of the premix is already doing the identity testing on the components being used in the premix, does that satisfy the requirement of 100% identity testing?Answered September 1st, 2010 by Expert:I assume that you are purchasing the blend. If that is the case, some sort of identity testing would need to be completed.
The FDA is very clear on requiring identity testing for all receipts of raw materials, without allowing skip-lot testing, as you point out. The NSF standard would also not allow you to rely on the blend manufacturer’s testing or Certificate of Analysis (COA) to identify the blend once the blend is received on your premises. I would suggest working with the blend manufacturer to determine a validated identity test that you could perform.
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