The NPGMA GMP Certification Program is designed to verify that member suppliers' manufacturing practices for dietary supplements conform to a standardized set of good manufacturing practices (GMPs) developed and approved by NPGMA. This program is based upon comprehensive third-party inspections of the manufacturing facilities and GMP-related documentation to verify compliance to the requirements of NPGMA GMP standards. This program ensures that all elements of the manufacturing process are reviewed to provide reasonable assurance that processes are sufficiently controlled so that products meet their established specification for quality, including identity, purity, strength and composition.
NPGMA member suppliers that meet a high level of compliance to the NPGMA GMP Standard and have received an "A" compliance rating after an NPGMA GMP audit will qualify for GMP certification and use of the NPGMA GMP certification seal. NPGMA GMP certification and display of the GMP certification seal demonstrates to suppliers, retailers, consumers and the public that products have been manufactured using good manufacturing practices and provide a means of self-assessment and independent evaluation of GMP compliance to the dietary supplement industry. NPGMA GMP certification represents facility and process certification versus product certification.
To maintain their NPGMA GMP certification status, certified companies must remain active NPGMA members, comply with all NPGMA supplier membership requirements, maintain compliance to the NPGMA GMP standards and terms of certification, pay an annual certification fee, and be re-audited every two years.
To ensure appropriate and adequate ongoing oversight of the NPGMA GMP certification program, NPGMA established a GMP advisory committee that provides input on current program materials and activities. The GMP Advisory Committee, under the direct supervision of NPGMA, is comprised of experts selected for their extensive knowledge and training in GMPs. Whenever possible, the committee members will have a diverse background, including food, dietary supplements, pharmaceuticals, and botanicals, representing the needs of the membership.
NPGMA auditors are utilized to conduct audits of supplier members according to established program audit protocol, utilizing the NPGMA GMP standards and audit documents. Auditors are selected and approved by NPGMA, based on qualifications and prior experience conducting audits and inspections of food or dietary supplement manufacturers. Auditors are trained in the NPGMA GMP standards and performance rating system, and have the required education, experience and training to conduct on-site audits.
The purpose of the on-site audit is to verify a company's compliance with the requirements of the NPGMA GMP standards. It also provides an opportunity for the exchange of information between the company and the auditor that will identify areas for improvement required to meet the requirements of NPGMA GMP standards. The auditor will inspect all facilities involved with the manufacturing, packaging, labeling, testing, holding and/or distributing of dietary supplements to ensure that all elements of the manufacturing process are reviewed to provide reasonable assurance that appropriate procedures are in place and that processes are sufficiently controlled so that products meet their established specifications for quality, including for identity, purity, strength and composition. Auditors assign a performance rating and submit their report to NPGMA for the final review and certification decision.