Natural Products Insider

JAN-FEB 2018

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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28 INSIDER January/February 2018 Best practices in navigating the relationship between supplement brand owners and their third-party manufacturer include self-examination and diligent research. In this INSIDER Q&A, experts in contract manufacturing discuss the aspects a brand owner should evaluate in a potential contract manufacturer, what should be outlined in an agreement and what ongoing quality assurance (QA) checks a brand owner should conduct during the partnership. INSIDER: What aspects of a brand owner's business must its executives understand/determine before it starts a search for a contract manufacturer? Jennifer Cusick, director, sales operations, Trividia Manufacturing Solutions: From a high-level perspective, the brand owners should self-identify what they require in four aspects of their business needs: experience, culture, service and solutions. The brand should set its expectations for customer service. Defi ning what "service" means up front can prevent diffi cult discussion later in the relationship. Brand owners should have full knowledge of the regulatory class and testing requirements for the specifi c cGMPs (current good manufacturing practices) for their product class. Heather N. D. Fairman, independent contractor, EAS Consulting Group LLC: The leadership of the own-brand company and its decision-makers need to understand the regulations that govern the industry their product category is in. They are then able to intentionally invest meaningful time considering their "brand equity" and brand integrity prior to selecting and partnering with a contract manufacturer. Brand value and consumer trust are key factors that should drive brand owners to ensure contract manufacturers are properly equipped and qualifi ed to provide and maintain the quality, compliance and safety of their products. Shabbir Akand, vice president, sales and marketing, NHK Laboratories Inc.: A brand owner's executives should have a complete understanding of the social message they want to portray. The Millennials, the largest demographic group, particularly demand transparency and a "clean label" from a supplement brand. A contract manufacturer should have the skills and mindset to facilitate in these matters. Transparency requires a contract manufacturer to disclose test results of all ingredients going into a product, in-process testing during manufacturing and fi nished product test results. Stan Glab, manager of product development formulations, Capsugel- Lonza: When selecting a contract manufacturer for dosage form delivery of a product, a brand should fi rst understand the kind of product it is developing and then look for a contract manufacturer that can address some of these needs and specifi c challenges for delivery. INSIDER: Which aspects of a contract manufacturer must a brand owner examine before choosing a partner? Mark A. LeDoux, founder, chairman and chief executive offi cer, Natural Alternatives International Inc. (NAI): Does the proposed manufacturing partner have a clear understanding of its role, and does it have the capacity both intellectually as well as physically to perform the duties indicated by the purchasing entity? If the facility has a laboratory onsite, an audit of the facility should be conducted, and reviews of prior production, testing and rejection criteria should be thoroughly discussed, and the testing equipment listed and functions clearly understood. Michael Finamore, CEO, Gemini Pharmaceuticals: Understanding the core competency of the manufacturer and its experience with the type of products offered by the brand owner is a good way to determine whether the brand owner is subsidizing the manufacturer's learning curve on these items, or whether the manufacturer brings an inherent value to the relationship. Aaron Secrist, director of quality and research & development, NOW Foods (at Capsugel-Lonza's quality summit in August 2017): Brands would be wise to craft and follow a strict program of vendor selection and management for manufacturers. A general outline of that process is: Determine and defi ne needs, create ethics and rules for engagement, search and send out bids for vendors, select vendors, defi ne contract terms and time frames, monitor relationships and performance, and determine renewals or cancellation of contracts. Jay Kaufman, president, Paragon Labs: The brand owner should consider years in the industry, GMP compliance through a review of warning letters, reputation within the industry and third-party certifi cations. Contract Manufacturing: Best Practices Successfully Choosing and Maintaining a Contract Manufacturing Partnership A supplement brand owner needs to identify its needs for service, regulations, social messaging and product development before it seeks a third-party manufacturer. Third-party resources such as GMP auditors, trade publications and consultants are available to help brand owners evaluate potential contract manufacturers. Frequent communication and regular in-person audits should be part of a brand owner/contract manufacturer relationship to build a solid foundation for successful products. INSIDER's Take

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