Natural Products Insider

MAR-APR 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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56 INSIDER March/April 2018 In today's technologically driven businesses, outsourcing to co-packers is the choice packaging method for enlightened dietary and food supplement manufacturers and distributors. Gravitating toward innovative contract packagers for their market-savvy expertise allows brands to focus on their core competencies and product development. Co-packers have always been a key—but quite often unnoticed—service, supply chain "middlemen" with the focus primarily on contract manufacturers. More recently, the spotlight is on raw ingredient material suppliers, due to looming enforcement of various Food Safety Modernization Act (FSMA) requirements. As the industry grows, so does the need for outsourced expertise. For a co-packer to maintain its competitive advantage, attract and keep new customers, and remain profi table, here are fi ve "golden rules" it should follow: 1 Truth in Advertising One of the fi rst steps most manufacturers and/or own-brand distributors take in sourcing a co-packer is via the least costly: internet searches. Co-packer webpages are examined and information gleaned by a company's procurement and/or compliance group. "A picture paints a thousand words," the saying goes, and quite often, "paint" is exactly what some co-packer websites merely do. Drawn by typical buzz phraseology— "state of the art," "years of experience," cGMP (current good manufacturing practice), and organic or trade association accreditation logos—contract customers are wooed to make the fi rst call. After a few exchanges of information and desired product packaging service discussions, deals made over the phone become disasters when the fi nished packaged product arrives on the customer's dock with multiple non-conformances, or worse, distributed directly from the contract packager's facility to market without being compliant. Brands must ensure their co-packers' websites depict the same integrity of services and information as would be found upon inspecting their facilities. The website is the fi rst line of engagement of trust and the virtual doorway into the establishment. 2 Facility Design, Capacity and Space Most co-packers service multiple customers and package multiple products. Having adequate space and a clean, well-equipped facility is key to providing capacity and increased production for the customer. Suitable size, construction and design is an FDA requirement stipulated in the various subparts of the food and supplement regulations (21 CFR 110 subpart 110.20(b), 21 CFR 117.20(b) and 21 CFR 111.20). Updated and automated equipment gives rise to increased effi ciency and manageable inventory systems, as well as readily available material resources. These factors serve to facilitate fl exibility for customer changes, and offer occasion for brands to expand their production while still obtaining rapid turnaround times. Consequently, brands are to likely experience less capital costs and increased opportunity to focus on creating new product launches. 3 Compliance Experience, Highly Trained and Qualifi ed Staff Co-packers should be well-versed in the contract customer's product regulations (e.g., 21 CFR part 110/part 117, 21 CFR part 111), with qualifi ed, experienced, technical personnel to oversee and lead in this area. Technical expertise, support of the customer's packaging needs and design, and proper regulatory and quality oversight from start to fi nish display intentional collaboration and commitment to ensuring a mutually benefi cial outcome. Co-packers are an extension of the contract customer. Providing the fi nished packaged and labeled product is a crucial deliverable for the manufacturer and/or brand owner. 4 Adherence to Customer Specifi cations and Requirements Co-packers must be aware that they are equally responsible for ensuring compliance of the brand owner's fi nished product. Therefore, before receiving inbound kits (e.g., customer product and components) for packaging or proceeding with any production runs, co-packers must ensure they understand the product and packaging specifi cations provided by the customer. This must be fi nalized and ensured as FDA regulations are applicable to the co-packers. Although co-packers typically perform a fraction of the production and processing of a fi nished dietary and/or food supplement or product, co-packers must be able to show compliance with applicable regulations, particularly if they are also involved in co-manufacturing the customer's fi nished product (i.e., further processing their product, then packaging). Co-packers that return either bulk packaged product or semi-fi nished unit product (e.g., unlabeled bottles) to customers are still required to adhere to regulations (21 CFR 111 subparts G and L, among others). 5 Quality Agreements Quality agreements are becoming an industry best practice, as they serve to defi ne the required cGMP responsibilities of the service provider and contract customer. These agreements also help avoid confusion and unnecessary disagreements in times of product and/or packaging issues. They help enhance and solidify partnerships; therefore, it is highly recommended that the co-packer provides a quality agreement if the customer doesn't present one of its own. Co-packers willing to follow these fi ve "golden rules" are more likely to increase their competitiveness to attract and maintain sustainable contract packaging partnerships, and thus, increase their profi tability. Heather Fairman, an independent consultant with EAS Consulting Group LLC (, serves as technical advisor for the SIDS DOCK Island Women Open Network (IWON,, an intergovernmental organization of Small Island Developing States (SIDS), which has all the rights and privileges of a United Nations organization comprised of 32 countries and who are embarking on developing a raw material market for the herbal supply chain. Contract Manufacturing: Co-Packing Co-Packers: '5 Golden Rules' to Stay Competitive and Profitable by Heather Fairman

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