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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26 INSIDER January/February 2019 same regulations as manufacturers that deal in tremendous volumes. While small-batch personalized production has substantial business opportunities, it comes down to how a manufacturer desires to grow its business, and how a brand owner's needs fi t into that process. Vetting in this regard is a two-way street. Fairman: All relationships are sustainable based on the measure of communication, interaction, mutual benefi t and respect. Some contract manufacturer/ own-label distributor relationships have lasted for more than 20 years, others for much lesser periods. The core mutual factor for lasting partnerships is an intentional commitment to quality and producing consistently compliant fi nished products. What limits longevity is most often related to the breakdown of communication between the parties that frequently results in either misbranded products (i.e., wrong or incorrect labels) and/or adulterated products (i.e., nonconformance to specifi cations or product contamination). LeDoux: The amount of effort required to vet a contract manufacturer, the establishment of contracts governing the relationship and the requirements for a quality agreement can be a lengthy process. As such, it is recommended that when a brand fi nds a compatible partner that the agreement should be for a minimum of fi ve years with evergreen provisions, assuming no breaches have taken place. A transparent relationship built on trust between honest dealers on both sides of the equation can lead to a fulfi lling relationship that can last decades. Finamore: Regulatory and practical changes to the marketplace have altered contract manufacturing relationships, which used to be mostly transactional. Since the advent of cGMPs and the growth of third-party certifi cations, consumer expectations have changed. Switching manufacturers is more challenging for the brand owner and requires more due diligence than before. INSIDER: How can supplement brands help increase the productivity and quality of their contract manufacturing partners? Griffi n: First, a brand should ensure its contract manufacturer is properly qualifi ed/ audited and a good fi t for the brand's needs. Second, simple product formulations and labeling is good. Complex formulas with more claims require more work and more documentation, so keeping them simpler helps reduce overall timing/ costs. Third, brands shouldn't operate in "rush" mode; it's best to plan for growth, and to understand the logistics and timing that need to take place to have a successful order placed and fulfi lled. Fourth, brands should have a regulatory strategy that involves diversifying vendors across product types or markets, and qualifying secondary manufacturers of a product or category of products. LeDoux: The best way for brands to help increase productivity and quality is to consolidate purchasing requirements into larger runs to spread out the cost of testing, validation and other costs that impact manufacturing. A rolling forecast allows the manufacturer to secure larger quantities of material at favorable prices, which helps maintain costs in material, alleviating the pressures contract manufacturers face. Also, changing formulations on the fl y provides challenges under the rigors of a GMP system that requires multiple disciplines from quality, research, production planning and packaging to sign off on modifi cations. Fairman: FDA's position on contract partnerships is stated in warning letters: An own-label distributor has the "ultimate responsibility" for distribution of its brand. Thus, brand owners should work closely with the contract manufacturer to ensure consistent compliance throughout the supply chain is accomplished. Own-label distributors should provide appropriate product specifi cations to the contract manufacturer. Also, they should have effective and credible marketing programs that create a sustainable market for the product. This measure of collaboration and accountability will help the contract manufacturer increase its productivity and quality and will provide sustainability of the inventory. Ung: It is important for the brands to have fi nished product specifi cation upfront and, ideally, a quality agreement with the contract manufacturer to help ensure brand owners are getting what they require and help eliminate misunderstandings. Often, customers are not sure of what exactly they want; this is when the contract manufacturer's research and development (R&D) team will work with the brand to develop a formulation and a product specifi cation. Good raw materials combined with good manufacturing and good communication equal a good product and great relationship. Finamore: Brands must serve as an integral part of the quality system of their contract manufacturer. From engaging in quality and manufacturing agreements to providing insight through audits and visits, the brand owner can offer a wealth of information and advice to even the best contract manufacturer. Contract Manufacturing: Best Practices Want to learn more about contract manufacturing best practices? Speakers from the SupplySide West 2018 workshop, "Managing Quality in a Contract Manufacturing Partnership," discussed critical considerations to ensuring strong partnership with contract manufacturers. In SupplySide West Podcast: Quality Systems in a Contract Manufacturing Partnership, Tara Couch, senior director of dietary supplement and tobacco services at EAS Consulting Group, discusses essential quality systems for an own-label distributor in a contract manufacturing partnership. In SupplySide West Podcast: The Basics and the Nitty Gritty of Quality Agreements, Kurt Schneider, president of Tech Bridge West, reviews the basics of quality agreements in a contact manufacturer partnership. Scan Here

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