Natural Products Insider

SEP-OCT 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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Page 46 of 68

42 INSIDER September/October 2018 A company that only markets, sells and distributes a product to the consuming public is a common supplement business model. These "own label distributors" that use different providers at different stages of the supply chain are just one example of numerous company types that exist within the industry. Regardless of who completes the manufacturing, packaging, holding or distributing of these products, the own label distributor must ensure the contracted party (contract manufacturer) is capable of delivering the product as specifi ed. That is just good business sense. Additionally, the preamble to the regulations on cGMPs (current good manufacturing practices) for dietary supplements and the Food Safety Modernization Act (FSMA) mandates the recipient of these services (brand owner or own label distributor) have knowledge of the products' quality. This means contract manufacturers are, or should be, hosting numerous audits of their contract manufacturers' operations. These assessments include ensuring the manufacturer is properly registered and implementing appropriate GMPs for production of the goods intended to be sold. FDA's position is the company whose name is on the bottle is responsible (or co-responsible) for the performance of the company that is manufacturing, packaging, storing or distributing the products. A critical step in this determination is the audit. FDA does not issue certifi cates of compliance to any company regarding any manufacturer's performance against GMPs. Nor does FDA recognize a third-party cGMP "certifi cation" as evidence of compliance with the regulations; having such a certifi cation cannot be used in lieu of auditing a manufacturer and is not considered suffi cient "qualifi cation" of that vendor. The responsibility for the performance of the contract manufacturer remains with the label owner, and that means routine auditing. Moreover, attempting to implement agreement-type language, whether in a stand-alone document or as part of service contract, to reassign regulatory obligations of the contract manufacturer to the client is not legal. A good contract manufacturer appreciates e ffi cient and frequent audits. Audits are integral to the partnership, not a "value added" portion of the business. The effi ciency of an audit rests on the ability of the auditor to get to the heart of the issue without needing to see multiple examples of the same kind of issue. Indicators found by simply reviewing the standard operating procedures (SOPs) can be affi rmed through documentation review; only one example is needed to affi rm the suspicions that arose during the "paper" evaluation of the operation. An auditor must be qualifi ed to evaluate a contract manufacturer's performance against existing regulations. That skillset and knowledge base is critical to the outcome from the brand owner's perspective, and is equally important to the contract manufacturer. Contract manufacturers appreciate the effi ciency, the lack of nonsense and genuine suggestions for improvements. Conformance with regulations is the requirement, and auditors should focus exclusively on that. It is not appropriate to insist on additional requirements apart from those required by regulations, but it is appropriate to ensure every aspect of the regulations as they are written is affi rmed by both parties. The critical elements for successful audits include selection of the auditing party, understanding the specifi c operations being performed by the contract manufacturers and their specifi c regulatory obligations, and routine follow-up to ensure activities of the contract manufacturer are at least equal to the last successful audit. The output of these audits should be considered useful to both parties. The contract manufacturer is now aware of any issues while the brand owner has continued the process of fulfi lling its own contractual obligations with FDA. The time spent over the course of the business relationship—if the qualifi cations are met by the audit, auditor, audit intent and audit performance—is highly valuable for both parties in meeting their individual GMPs and safety obligations. As chief operating offi cer, Jim Lassiter oversees all consulting operations at Ingredient Identity ( He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). Lassiter has served on numerous industry and trade boards. Auditing a Contract Manufacturer: Essential for Both Parties by Jim Lassiter Contract Manufacturing: Audits Contract Manufacturing at SupplySide West Learn more about regulatory responsibilities in a contract manufacturing partnership, along with insight on vendor qualifi cation, quality agreements and more, during the "Managing Quality in a Contract Manufacturing Partnership" Workshop on Saturday, Nov. 10 at 8:30 a.m. at SupplySide West in Las Vegas. Scan Here

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