NPA GMP Standard

The Natural Products Association was founded in 1936 to promote and protect the unique values and shared interests of retailers and suppliers of natural nutritional foods and natural products. NPA is a nonprofit 501(c)(6) association whose mission is to unite a diverse membership, from the smallest health food store to the largest natural products supplier. We champion consumers' freedom of choice in our marketplace. We strengthen and safeguard retailers and suppliers. We build strong markets to fuel industry growth. We act together with uncompromising integrity, and we encourage all to reach ever-higher standards of quality. We are the largest and oldest trade association in the natural products industry, representing over 1,900 members accounting for more than 10,000 retail, manufacturing, wholesale, and distribution locations of natural products, including foods, dietary supplements, and health/beauty aids.


Background

NPA has always taken a leadership role in promoting quality standards and has developed proactive certification programs for that purpose. NPA was the first organization to offer a third-party GMP certification program for the manufacturing of dietary supplements and dietary ingredients. NPA established GMP standards for dietary supplements in 1999 and updated the standard in 2000. At time of publication, these GMP standards represented industry's best practices and served as the basis of the NPA GMP Certification Program as well as establishing a higher level of control than was currently required by the FDA.

In June 2007, the FDA published the final GMP regulation specific to dietary supplements (21 CFR 111). In order to keep the NPA GMP Certification Program relevant and reflect the highest level of industry good manufacturing practices, the NPA GMP Standard has been revised to include all of the FDA GMP requirements of 21 CFR Part 111 and certain requirements from the 2000 version of the NPA GMP standard that exceed requirements of the FDA GMPs, or reflect best industry practices, and/or are necessary for the evaluation of compliance to the NPA GMP standard.

Purpose
The NPA GMP Standard serves as the basis for the GMP Certification Program. All program requirements and support materials relate to the NPA GMP Standard. The NPA GMP Standard is a living document and will be reviewed and potentially updated to reflect current best practices, advances in technology, and ingredient and product knowledge.

Scope
The NPA GMP Standard established good manufacturing practices requirements for and dietary supplement manufacturers, dietary ingredient manufacturers, and distributors that want to be certified through NPA's GMP Certification Program. All companies, including dietary ingredient suppliers, that are seeking certification through the NPA GMP Certification Program will be required to meet the NPA GMP Standard in all areas that are applicable to the manufacturer's, distributor's or supplier's operations.