The objectives of the GMPs from the FDA’s perspective are to provide the general public with unadulterated products that are not misbranded and meet their respective label claims. Thus, those manufacturing firms and distributors that seek to evaluate their state of compliance, have an expert third-party review their facility in preparation for an FDA inspection, or need very skilled and detailed assistance with their quality system to bring it to a state of compliance can use a third-party certifier to address that regulatory need.
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Explore This IssueFebruary/March 2015
To assist firms and present the 815-page GMP Final Rule in a more condensed, palatable form, NPA offers GMP education and training alongside the certification program. The seminar education has expanded to incorporate claims training to highlight the differences between permissible structure/function claims and unauthorized disease claims, New Dietary Ingredients, and requirements of various business models to the GMP Final Rule by former top agency officials.
NPA has recently partnered with UL, which has more than 100 years of experience in the testing and certifying of products. Its name is recognized universally by retailers, consumers, and suppliers of U.S. products, materials, components, and systems. NPA and UL are developing education to train both quality auditors and the dietary supplement industry. One problem with third-party auditing and certification bodies is the lack of transparency displayed so firms can know the true quality of their auditors. NPA and UL are developing unique training in GMPs, Safe Quality Foods, and new changes with the Food Safety Modernization Act designed specifically for auditors. The process in how auditors are qualified to perform quality audits will provide much needed transparency and enable auditors to better think like agency investigators.
Third-party quality audits are a tool that should be used more in the dietary supplement industry as a management tool for determining the effectiveness of one’s quality systems in place. There is no excuse for failing to meet FDA cGMPs. A plethora of resources is available to ensure firms are compliant. Don’t risk falling victim to an avoidable mistake—take advantage of resources that have regulatory experience to help navigate your way through compliance.
Dr. Fabricant is the executive director and CEO of the Natural Products Association. Reach him at Daniel.Fabricant@npainfo.org. Dr. Hilmas serves as senior vice president of scientific and regulatory affairs. Reach him at firstname.lastname@example.org.
More on Industry Education
NPA’s GMP education sessions usually take place at industry events and tradeshows in the U.S., they have also been conducted for firms onsite domestically and in Asia, Europe, and South America. The education seminars have taught over 1,000 industry stakeholder firms as well as FDA regulators. NPA also holds monthly webinars in its “Wednesday Webinar” series on a variety of issues of interest to industry stakeholders—from GMP compliance, NDI notification, and adverse event reporting requirements, to didactic approaches on how to write and qualify structure/function claims. The organization is ensuring that the industry is properly trained and is manufacturing the best possible ingredients and products for consumers. NPA employs two of the FDA’s former top heads in dietary supplement regulations and combines its experience in training the FDA field offices with the safety and quality record of the UL company.—D.F. & C.H.