Natural Products Insider

SEP-OCT 2017

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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66 INSIDER September/October 2017 Supplements need to be tested. That's per FDA's regulations, and spurred by the common-sense desire to ensure that products entering the market are safe, meet label claims and are made with quality ingredients. But testing is easier said than done, with many products containing multiple ingredients or ingredients enhanced to certain— sometimes proprietary—standardizations. Supplement brands and the contract manufacturers that create the products often partner with contract labs (outside companies that test products and ingredients) to ensure products are tested in scientifi cally valid ways. This INSIDER Q&A with industry experts discusses navigating the complex relationship between supplement brand owners/contract manufacturers and a third-party contract laboratory. INSIDER: Why would a supplement brand/contract manufacturer want to partner with a contract lab? Jeff Stassi, senior program development manager for dietary supplements, Covance Labs: Many contract manufacturers may have specifi c analytical capabilities, but not the scientifi c depth or the infrastructure to have a full-scale laboratory. Contract labs develop and attract experts not only in general analytical testing, but in specialty areas. Contract labs can execute and confi rm that specifi cations are met, especially in the fi nished product. Tara Lin Couch, Ph.D., independent advisor of dietary supplements, EAS Consulting Group: The own-label distributor or contract manufacturer is responsible for ensuring that the laboratory complies with all a pplicable 21 CFR 111, cGMPs (current good manufacturing practices). This is a much easier process if the laboratory and own-label distributor/ contract manufacturer are partners. Many laboratories will also be conducting experiments to verify that test methods employed to demonstrate that material and product specifi cations are met are scientifi cally valid. Jacob Teller, quality assurance lab manager, Analytical Resource Laboratories: Contract labs have the dedicated resources to update certifi cations and knowledge on current methodologies and technologies. A partner lab will also take objective looks at product quality and work diligently to assist the brand or contract manufacturer to improve its in-house systems and processes, allowing them to become the best at what they do. Holly Johnson, Ph.D., laboratory director, Alkemist Labs: Few novel ingredients are accompanied by test methods and/or recommended testing partners that know how to test those materials. Contract labs can help develop methods and then share those with ingredient suppliers that can provide their customers with products and test methods specifi cally for them. If a contract lab is well respected, its certifi cate of analysis (CoA) can lend confi dence. Tammy Blakemore, general manager, SORA Labs: Contract labs offer testing services that may not be feasible for a contract manufacturer to handle in-house for various reasons. Complex technique-driven methods are not easily mastered, often taking years to develop and run with expertise. Some testing is not cost effective. Lab safety concerns may also arise with methods that use certain hazardous chemicals or known carcinogens. Erik Eberhart, global business develo pment, UL: Manufacturers want to partner to help monitor and drive integrity in global supply chains, optimize product performance and protect brands. This includes the obvious objective and non-biased partners that can provide more accurate fi ndings, better risk mitigation, and, ultimately, brand protection by removing subjectivity. Karine Aylozyan, quality assurance technical director/CEO, Micro Quality Labs Inc.: Contract manufacturers should partner with third-party labs as it gives an approval by an outside ISO17025 certifi ed lab. Also, it should be less expensive to contract out as third-party labs' prices are normally set per volume, and the cost would be greater if performed in-house due to standard cost/instrument maintenance. Contract manufacturers would have to invest in a senior level chemist, as well as Contract labs help supplement brands meet product specifications, regulations and consumer expectations. Before partnering, brands should ensure contract labs have proper accreditation, and the staff is properly trained. During onsite audits, brands should review standard operating procedures (SOPs), test methods and raw data. Tips for a Successful Contract Lab Partnership INSIDER's Take Contract Labs Hear more from Tara Lin Couch, John Atwater and Heather Neves Duncan-Fairman during the "Selecting and Testing Your Contract Laboratory" Workshop on Tuesday, Sept. 26 at 9 a.m. at SupplySide West in Las Vegas. This session is underwritten by Alcami, Analytical Resource Laboratories, Eurofi ns, Micro Quality Labs and Midi Labs. Scan Here Contract Lab Insights at SupplySide West

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