Natural Products Insider

APR 2012

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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Page 15 of 60

Industry Continues to Address Quality Control The American Herbal Products Association (AHPA) now of fers more than 30 standard operating procedure (SOP) templates to help companies meet dietar y supplement cur rent good manufactur ing pract ice (cGMP) compl iance. The SOP var iance templates were developed for an AHPA educational seminar, "cGMP Compliance Series Teleseminar : Variances," by Staci Eisner, vice president of quality for Cortex Scientific Botanicals and chair of the AHPA Government Relations Committee. The templates focus on variances, which are exceptions or departures from approved protocol. Under FDA regulations for cGMPs, variances must be detected, investigated, documented, explained and addressed. AHPA's SOP templates will of fer newer companies a jump-star t with cGMP and established businesses with a means to examine their current SOPs. The templates include fully customizable examples of SOP repor ts and log forms, including: unplanned events, calibration failures, nonconforming mater ials, planned deviations, production fai lure, corrective and preventative actions, out-of-specification investigations, customer complaints, returned goods, reportable foods and recall procedure. American Laboratories Inc. (ALI), a manufacturer of pancreatin, pepsin and proteins, upgraded its qual i ty management system wi th MasterControl, which is expected to faci l i tate compl iance management by automating and managing documents and change control, training management, audits, corrective and preventative actions, customer complaints, nonconformance disposition, deviation handling and other cGMPs (current good manufacturing practices), good documentat ion pract ices and good laboratory pract ices processes critical to regulatory compliance. MasterControl's web- based application will be implemented in all three ALI facilities. Kyowa Hakko Bio Co. Ltd. launched a quality seal for its unbranded amino acids, allowing its customers to label their products with the "Kyowa Quality™" seal. The mark is designed to show that its line of unbranded amino acids and related compounds are produced using the same sophisticated technologies and high-quality standards as the company's branded ingredients. Manufacturers choosing Kyowa's commodity products can co-brand with the Kyowa Quality seal to let consumers know high- quality ingredients were used. "Through our proprietary, science-backed fermentation technologies, Kyowa offers an extensive line of high-quality amino acids that support healthy metabolic activity," said Karen Todd, Kyowa Hakko USA director of marketing. "Our customers can convey their dedication to pure, scientifically tested ingredients by participating in the Kyowa Quality program." Scientifically Proven Lyc-O-Mato® – The original natural tomato complex. Over 50 clinical studies based on a unique composition of phyto-nutrients. Ƈ Extensively researched Ƈ Proven safety record Ƈ Patent protected Please visit us at Supply Side East, booth #501 naturalproductsinsider ¡ com 11 IN THE NEWS

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