Good Manufacturing Practices - Compliance and Certification

Good Manufacturing Practices (GMPs) refer to establishing manufacturing procedures, documenting and following these procedures, the training of operators to follow these procedures, and processes for the investigation and corrective actions following deviations from these procedures. The purpose is to make sure the products are manufactured safely and that quality is assured. For many products, GMPs are established by regulatory authority. For example in the U.S., pharmaceutical products, medical devices, and foods each have their own GMPs (called cGMPs – c is for current) that are established by the FDA. In addition, the FDA has recently established cGMPs for dietary supplements, and these are being phased in over three years, with a final completion date of December 2009. The FDA expects manufacturers of dietary supplements to comply with cGMPs. The FDA does not certify companies to be in compliance with the cGMPs. Instead, when the FDA inspects a manufacturing facility, it will issue “observations” which in fact identifies deficiencies, whereby the manufacturer will need to correct these deficiencies. No certification is issued. On the other hand, there are a number of independent bodies that will inspect manufacturers and certify compliance with GMPs. In the U.S., prior to the performance of the FDA cGMPs, two certifying organizations were the Natural Products Association (NPA) and NSF International. Both these organizations had essentially the same standards for certification (in fact, contrary to popular belief, NSF licensed the GMP requirements from NPA). NSF allows a mark on the certified products, but NPA does not. NSF is a private company. NPA is an industry trade association. At present, since the FDA has issued the new dietary supplement cGMPs, and the cGMPs trump all other GMP programs, these organizations have in fact converted their GMP programs to at least meet, and I know that in the case of the NPA GMP program, exceed, the FDA cGMPs. So companies like NOW Foods can continue to be certified by the NPA, as we will thereby also comply with or exceed the FDA cGMPs.