 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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Our company is a wholesaler of finished products. We reside in the same building as our cGMP-certified manufacturer, but are separate corporations. The manufacturer supplies us with finished products, which are stored on the premises but separately from their warehouse. What cGMP rules apply to us as a wholesaler?Answered September 1st, 2010 by Expert:As a holder of dietary supplements, you would be subject to 21 CFR Part 111. Specific requirements would include mechanisms for tracking and reporting recalls, returns, complaints, and adverse events; a record-retention program; and warehousing requirements, including sanitation and segregation.
If you are providing the labels for the products, then the labeling requirements found in 21 CFR Part 101 would also apply. NSF provides an auditing program for distribution and warehouse facilities with an audit checklist and guidance document specific to your type of operation.
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