Natural Products Insider

SEP-OCT 2017

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 September/October 2017 Contract Manufacturing: Ingredient Sourcing Test or Brand Owners Beware by Michael Finamore A critical component for the brand owner is ensuring its supplement contains the ingredients specifi ed in the formula at the appropriate amounts. The cGMPs (current good manufacturing practices) are clear about the requirement for both ingredient and fi nished product specifi cations to be created for each item to identify it and quantify potential adulterants or contaminants. Historically, the brand owner delegated the responsibility for testing the raw materials to the designated contract manufacturer, and often relied on the contract manufacturer's fi nished product certifi cate of analysis (CoA) as evidence of the fi nished product compliance with the required specifi cation(s). With all of this done out of sight of the brand owner, what assurances are available to ensure the cGMP testing requirements are being met? Does the contract manufacturer have an in-house lab suffi cient for the scope of its business model? Does the contract manufacturer outsource some or all its testing? All too often, this key analysis is overlooked or only given a cursory inspection during a plant visit or audit. A nice room, decorated with fancy-looking instruments and staff in lab coats and safety glasses usually provides the blanket assurance to the brand owner that the contract manufacturer can handle the job—and, unfortunately, the defi ciencies in the lab or its operations only become apparent after there is an issue. Thus, time spent up front understanding how testing on a product is done is well worth the effort in the long run. Frankly speaking, the contract manufacturer's in-house lab is unlikely to either have the expertise, equipment or time to run every test required to meet specifi cations. Contract manufacturers usually manage a mix of in-house testing coupled with the use of qualifi ed third-party labs. Of course, if a contract manufacturer does not operate an in-house lab, everything must be outsourced, which is fi ne so long as the third-party lab(s) can perform the required testing. Contract Manufacturer's In-House Lab Many contract manufacturers have made the investment to bring a lot of their routine testing in-house. While this certainly saves time, it is an investment that takes time to achieve a return. However, for most quality contract manufacturers, the peace of mind in having a competent in-house laboratory offsets the investment in millions of dollars of equipment and trained staff. Additionally, the turnaround time from a • DIETARY SUPPLEMENTS • COSMETICS • OTC PHARMACEUTICALS • HOMEOPATHICS • ANIMAL CARE PRODUCTS 248 Main Street. Lancaster, NH 03584 For more information, please contact us at Custom Manufacturing and Packaging FOR MORE THAN 150 YEARS, TRIVIDIA MANUFACTURING SOLUTIONS HAS BEEN COMMITTED TO THE HIGHEST STANDARDS OF QUALITY, CUSTOMER SERVICE AND VALUE. Extensive expertise in developing, manufacturing and packaging: • LIQUIDS • LOTIONS • TABLETS • CAPSULES • CREAMS • GELS VISIT US IN VEGAS AT SSW BOOTH #B148

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