Natural Products Insider

JAN-FEB 2019

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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20 INSIDER January/February 2019 Supplement brands that choose to outsource manufacturing cannot outsource the care it takes to create safe, legal and successful products. Brands must consider a contract manufacturer as a true partner based on communication, transparency and trust—not a business deal based on low prices. In this INSIDER Q&A, contract manufacturing executives and business consultants discuss the best way for brands to make the most out of their contract manufacturing relationships. INSIDER: Why is it so important for supplement brands to vet potential contract manufacturers before they sign a contract? Steve Holtby, president and CEO, Soft Gel Technologies Inc.: Selection of the right contract manufacturer is an intermediary step in building longer-term success. Without a detailed, comprehensive transition plan and effective ongoing management of the partnership, even the best contract manufacturing relationship will fail to achieve its full potential. Effective management means documenting all processes to avoid ambiguity about who is responsible for what. If supplement brands don't verify their potential contract manufacturers, they could have their fi nished products manufactured in a [non-compliant] plant. Thus, they will be affi liated with this subpar plant and could be subject to recalls. FDA could act against them for not qualifying their contract manufacturer. Mark A. LeDoux, chairman and CEO, Natural Alternatives International Inc. (NAI): Prior to initiating a contract, it's essential that brands secure a level of comfort with expertise; fi nancial condition; insurance coverage; and scope of acumen in formulation, material acquisition, processing and testing of its contract manufacturer. Labeling laws and regulations as well as myriad location- specifi c requirements, e.g., Proposition 65 label warnings in California, etc., are strict and binding. Ignorance of the law in this area is not an adequate legal defense. It is also helpful to receive copies of Form 483s issued by FDA and any corrective actions taken to cure observed cGMP (current good manufacturing practice) defi ciencies and FDA close-out letters, if they exist. Michael Finamore, CEO, Gemini Pharmaceuticals: It is important to vet manufacturers because of the legal requirements and implications that arise from a signed contract. A contract is designed to defi ne the parameters of the relationship and ensures that all parties to the contract are aware of its contents and the responsibilities it can assign. Therefore, when this contract is executed, it rightly assumes that all parts of the relationship leading to this moment have been investigated by both sides, and everyone is comfortable with the foundations of the relationship. Eugene Ung, CEO Best Formulations: A contract manufacturer is not just a vendor to a supplement brand; the contract manufacturer is an extension of that brand. As with any important department within an organization, business disciplines should be applied, such as communicating expectations, setting key goals/objectives, etc., and expectations need to be clearly communicated. Brands must visit/audit the facility where the products will be made and meet the team. Gabe McCutcheon, global head of fi nished produ ct operations, Lonza Consumer Health & Nutrition: To create a true partnership, i.e., one that can be long-lasting and mutually benefi cial, both organizations need to be aligned on several important areas. First, supplement brands should vet contract manufacturers based on their own business goals. For example, if a company wants to be on the cutting edge of product development, the contract manufacturer should be innovative. Second, it's critical to vet contract manufacturers on adherence to regulations. Going to visit a contract manufacturing site is invaluable. If a product is intended for global supply, brands should ensure the contract manufacturer understands and complies with regulations in all sales territories. Brandon M. Griffi n, CEO, REJIMUS (formerly Ingredient Identity): Many supplement brands have taken for granted the compliance of their supply chain or relied on the third-party GMP certifi cates as "compliant enough" and think they need to do nothing more. This is not the case; brands must be responsible for the compliance of their products—regardless of the manufacturer or certifi cations it holds. Moreover, it is not just about compliance, but also about the contract manufacturer's capacity, its reliability, its regulatory background and history of inspections, its locality and logistics, its internal vs. external operations to ensure consistency of the product(s) over time, the structure of its executive management team and its historical fi nancial stability. Choosing, Reviewing and Improving Contract Manufacturers Contract Manufacturing: Best Practices Contract manufacturers should be treated as an extension of a supplement brand—with proper evaluation and accountability practices. Transparency and open communication between a supplement brand owner and its contract manufacturer builds trust in the supply chain. Supplement brands can help their contract manufacturers by establishing solid product specifications and supporting products with sufficient marketing. INSIDER's Take

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