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Explore This IssueFebruary/March 2015
Wherever you travel around this country—and even internationally—you will likely hear the same rhetoric from dietary supplement manufacturers. Firms claim they have quality, something that their competitors do not, and they are doing it the right way despite not allowing an external audit for quality and compliance by a third party. When one of us hears this from a company, we typically respond by asking how they know this to be true, and we are left feeling surprised that more dietary supplement firms do not use a quality audit from a third-party certification organization to demonstrate the adequacy of their quality systems, considering its benefits to benchmark continuous process improvement and relatively low cost.
When you look up the word quality, you will find that it is an attribute or defining characteristic that has become the standard as measured against other things of a similar kind. In a world where we group according to the buckets of good, better, and best, quality is the degree or extent along the scale to that asymptote we call perfection, an impossible point we can never reach. Many may not be familiar with the teaching of W. Edwards Deming and his 14 points for continuous process improvement, but they are quality concepts that have passed the test of time. Deming was a U.S. statistician of mathematical physics, and a pioneer of modern quality management. He developed the founding principles of Total Quality Management and the System of Profound Knowledge. Deming introduced the DMAIC and PDC(S)A acronyms, which have been quoted in every quality seminar since the 1980s. DMAIC stands for Define Measure Analyze Implement and Control and PDC(S)A stands for Plan Do Check (Study) and Act. These acronyms and Deming’s 14 points of quality management gave birth to Six Sigma by Bill Smith of Motorola, many of the concepts of ISO9000 series and the ANSI Q90 series standards issued today for quality improvement, and Lean training of the ‘90s.
Keeping Up to Standard
Intrinsic to demonstrating quality for any firm is implementation of an external quality audit and certification to an industry standard. Given the choice available to the industry, there is no shortage of auditors for part 111 current Good Manufacturing Practices (cGMPs), but there is quality and, therefore, value in the services of an audit. The results of a third-party quality audit provide a benchmark assessment of the adequacy of the existing program as it sits statically in the present, and an assessment of weaknesses to drive continuous process improvement into the future.
The Natural Products Association (NPA), formerly the National Nutritional Foods Association, created the first GMP standard for performing quality audits as well as certification in the dietary supplement industry. NPA is committed not only to advocating for the rights of manufacturers, suppliers, and retailers to have a marketplace in which to sell products but also to consumers having access to quality products in order to maintain their health and well-being. NPA has developed a long and diverse array of self-regulatory initiatives and programs, all of which were firsts for the natural products and dietary supplement industry.
To advocate both consumer and industry concerns, associations will typically develop self-regulatory programs or initiatives which demonstrate industry transparency and maturity, and provide the consumer valuable information that can be used to evaluate products. The public and private benefits of industry self-regulation are numerous, and they typically outweigh the costs incurred to industry. First, self-regulatory programs and initiatives may lead to the establishment of product or ingredient standards to ensure quality and safety. In turn, these standards may facilitate the emergence of markets by establishing baseline levels of product quality and safety; result in improved consumers’ understanding; impart brand recognition through seals/marks representing third-party certification; induce brand loyalty; and garner trust of new products.
Associations will typically develop self-regulatory programs or initiatives which demonstrate industry transparency and maturity, and provide the consumer valuable information that can be used to evaluate products.
Standard setting and implementation can be a further benefit to manufacturers by lowering production costs, which can be passed on to the consumer. For example, a standard can be established to assist manufacturers in producing interconnecting or interchangeable parts. Especially in high-tech industries, standards assure a manufacturer that if its product conforms, the product will interconnect with complementary or rival products of similar specifications. But most important in the days of the global marketplace is that industry self-regulation helps consumers evaluate products and services by providing information about the qualities and characteristics of the seller’s products.
Filling a Need
In 2014, NPA’s GMP Certification Program entered its 15th year of verifying for consumers that dietary supplements are manufactured according to the highest standards. Prior to the GMP final rule roll out in 2007, dietary supplement manufacturers were only required to adhere to GMPs for foods (21 CFR Part 110), which were largely enforced by local and state health departments. The association recognized that while food GMPs are certainly significant in regards to controlling general sanitation practices and monitoring sink log records, they did not address product quality with regard to specifications including identity, purity, strength, and composition, as well as incorporating process control and quality control features to prevent mix-up and contamination which could potentially render a product adulterated. NPA in conjunction with some of the other industry trade organizations helped develop a model for the GMP regulations and passed it to the FDA in late 1995. This model served as the basis for the 1997 FDA proposed GMPs in the form of an advanced notice of proposed rulemaking.
Rather than wait for the FDA to finalize the proposed rule, the association began developing its own GMPs to ensure quality. The NPA GMP audit program was launched in January 1999, with the first certifications issued in July of that same year. NPA’s GMP education seminars were also rolled out in 1999. The program has awarded certification to more than 106 member companies, ranging from some of the largest manufacturers to the smallest in the industry, including both domestic and foreign firms, representing more than 45,000 finished products and thousands of raw materials.
When the program was first launched, the goal of the GMP Certification program was to ensure that all elements of the manufacturing process are reviewed so that products meet their intended quality. Third-party on-site inspections of manufacturing facilities cover such areas as filth control and cleanliness of equipment, facility, and grounds, establishment of a quality control unit, test methods, expiration dating, and procedures for storage and distribution. The third-party certification program includes inspections of dietary supplement manufacturing facilities to determine whether specified performance standards on a number of measures—including quality control, cleanliness, receiving, and testing of raw materials—are being met. A member supplier must receive an “A” rating in order to be certified. Those who receive either a “B” or “C” rating must correct deficiencies and submit for a re-audit.
The NPA GMP program was amended in 2008 to incorporate the requirements introduced in the long awaited FDA cGMPs Finalized Rule for dietary supplements (21 CFR Part 111). The program holds great value for the industry for a number of reasons but none more significantly than reducing exposure to regulatory vulnerability. It is important to note that a product failing to meet the FDA cGMPs is considered a technical adulteration. FDA will not provide help to a manufacturer or distributor to prepare for the GMP inspection, nor will it offer certification.
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.
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 email@example.com.
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.