June 9, 2009
June 2009 marks the second stage of FDA GMP (good manufacturing practice) enforcement for dietary supplement manufacturers. However, the industry still reels with doubts and questions about GMP readiness. Certain issues remain cloudy and common misconceptions need to be addressed.
When do FDA's GMPs take effect?
FDA has staggered compliance to the new GMPs over a span of three years, depending on the size of the company.
More than 500 employees by June 2008.
20 to 500 employees by June 2009.
1 to 20 employees by June 2010.
Who needs to comply with the new GMPs?
The cGMPs apply to any company that "manufactures, packages, labels or holds" a dietary supplement. While primarily targeting domestic firms, foreign companies shipping products for marketing in the United States must comply with the new regulations and should make their records available on request for FDA inspection.
FDA's GMPs do not apply to suppliers of raw material or ingredients, unless they are packaging and selling raw materials directly to consumers. The onus is solely on the dietary supplement manufacturer to check raw materials and ingredients for quality, potency and veracity. Testing methods have not been specified by FDA except to say that testing methods should be "based on a statistically sound program that is documented to show compliance with quality controls." However, if the supplier's reliability has been determined, the manufacturer may rely on a supplier's certificate of analysis of inactive or inert ingredients.
The new GMPs do not apply to retail stores, warehouse and storage facilities that hold dietary supplements for the sole purpose of directly selling to consumers.
Should packaging/labeling units be GMP ready?
Manufacturing and packaging/labeling units would each need to comply with regulations related to their specific operations. The manufacturer needs to comply with all the manufacturing GMPs, including testing of the finished batch. The packager/labeler would need to comply with requirements pertaining to packaging and labeling operations, as well as general requirements pertaining to personnel, the physical plant, quality control and other related areas.
What about personnel?
Under the new GMPs, personnel should not only be qualified for the job, but also undergo systematic training for the job. Written training programs must be in place and training must be conducted consistently. In addition, a manufacturer is required to identify quality control (QC) personnel. These identified personnel must be qualified, and given clearly defined responsibilities separate from other job descriptions they might perform. QC operations may be performed in-house or by a contractor.
The new GMPs go a long way in clearing misconceptions about the dietary supplement industry. In helping to establish specific controls in each area of dietary supplement manufacturing, it will ensure products meet the specified quality with proper packaging and labeling. As more companies align themselves to the new rules, it will help raise the credibility of the nutritional supplement industry.
Andrew M. Goldman is the director of marketing for Nutricap Labs, a GMP-certified, full-service vitamin supplement manufacturing company based in Farmingdale, NY. Nutricap Labs primarily manufacturers nutritional tablets, capsules, powders, liquids and creams, but also offers label and packaging design services, marketing solutions and order fulfillment services to its customers. Contact Nutricap Labs at (800) 659-6818.
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