Natural Products Insider

NOV-DEC 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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60 INSIDER November/December 2018 The dietary supplement industry is an industry of contracting. Many products are manufactured by one company, packaged at another, tested by a contract laboratory and distributed by yet another company, all at the direction of the product owner or own label distributor. Regardless of where operations take place, FDA has made it clear the own label distributor is responsible for compliance to the regulatory requirements in 21 CFR 111, "Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements." The development and implementation of essential own label distributor quality systems and programs will go a long way to ensure GMP compliance. Developing a new dietary supplement product begins when a product owner, or own label distributor, has a desire to create a product that will be able to make distinct dietary ingredient label claims, usually with a unique combination of ingredients, ingredient levels and/or dosage forms. The raw materials or components are identifi ed and listed with the required amounts of each to prepare a product formulation. These two items, the proposed product label claims and the product formulation, allow the own label distributor to draft one of the essential documents required for all dietary supplement products: a fi nished product specifi cation. This is only a draft fi nished product specifi cation because the own label distributor must also understand the manufacturing processes that will be employed to ensure the specifi cation appropriately addresses all the categories required in 21 CFR 111.70(f) of identity, purity, strength, composition and limits on potential contaminants. In accordance to 21 CFR 101, "Food Labeling" (which applies to dietary supplement products because dietary supplements are classifi ed as a food by FDA), all dietary ingredients intentionally added into a product formulation must meet at least 100 percent of the product label claim. This requirement means the acceptance criteria assigned on the fi nished product specifi cation for the strength parameter of each dietary ingredient must also have a minimum of at least 100 percent of the label claim. The own label distributor must not only have knowledge about the manufacturing process for establishing specifi cations, but also account for manufacturing variabilities. Another critical consideration is the variability of the test methods that will be used to test for the strength of all dietary ingredients in the product. The own label distributor must then also coordinate with the laboratory to determine what scientifi cally valid test methods will be employed and what variabilities are associated with those methods. Clearly, the own label distributor must develop a strong relationship with its contracting partners to gather all this information. Good relationships are built on trust. In a GMP environment, however, trust must be verifi ed and documented. This is where a formal qualifi cation of the contract manufacturer, contract laboratory or any other contractor comes into play. The own label distributor must have a process to qualify all its contractors to ensure compliance with 21 CFR 111 and that the fi nished dietary supplement product will also meet the labeling requirements of 21 CFR 101. The qualifi cation is an evaluation of the contractor's quality system on paper, captured on a contractor qualifi cation questionnaire and via an onsite audit of the facility to verify that the quality system is being followed in practice. Issues found during the audit must then be remediated through appropriate corrective and preventive actions (CAPAs). At the contract manufacturer, the master manufacturing record (MMR) incorporating the product formulation and detailing the manufacturing process that will be used for the own label distributor's product should then be reviewed and approved by the own label distributor. Thereafter, periodic monitoring of executed batch production records (BPRs), which include product testing certifi cates of analysis (CoAs), should also be performed. The establishment of own label distributor fi nished product specifi cations and qualifi cation of all contractors are just two of the essential quality systems the own label distributor must put in place. Tara Lin Couch, Ph.D., senior director of dietary supplement and tobacco services at EAS Consulting Group (easconsultinggroup. com), is an analytical/ organic chemist with exceptional analytical abilities and more than 30 years of diverse laboratory and regulatory experience in academic, fi eld, contract and manufacturing environments. Contract Manufacturing Essential Quality Systems for an Own Label Distributor by Tara Lin Couch, Ph.D. Contract Manufacturing at SupplySide West Learn more about quality systems from Tara Couch, Ph.D., 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. supplysideshow.com Hear Couch preview the session by listening to SupplySide West podcast: Quality systems in a contract manufacturing partnership. Scan Here Scan Here

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