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Explore This IssueFebruary/March 2015
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.