 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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Do cGMPs for dietary supplements permit any type of reduced testing program for raw materials, other than simply relying on a COA from a qualified supplier? For example, can reduced testing frequency and/or the use of different specifications be applied to a raw material after a track record of passing test results has been established for a given supplier of a material? (This assumes that ID testing is always performed.)Answered September 1st, 2010 by Expert:The FDA and cGMPs absolutely allow for skip-lot testing as part of your overall testing program. A skip-lot program would involve getting that track record you are referring to by performing the tests, and then after sufficient data gathering, reducing the testing for the entire lot of material or perhaps for one test on your specifications.
I would not advocate having multiple specs, but rather defining the skip-lot program as part of the spec or part of an overall testing plan standard operating procedure.
You are correct to point out that the FDA does not permit skip-lot testing for identity. So each and every lot of raw materials received will need to have this testing completed.
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