NPA GMP Certification Program Overview
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 specific to the manufacturing of dietary supplements and dietary ingredients. In addition, 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 served as the basis of the NPA GMP Certification Program as well as establishing a higher level of control than was currently required by 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.
The NPA 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 NPA. This program is based upon comprehensive third-party inspections of the manufacturing facilities and GMP-related documentation to verify compliance to the requirements of NPA 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.
NPA member suppliers that meet a high level of compliance to the NPA GMP Standard and have received an "A" compliance rating after an NPA GMP audit will qualify for GMP certification and use of the NPA GMP certification seal. NPA 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. NPA GMP certification represents facility and process certification versus product certification.
To maintain their NPA GMP certification status, certified companies must remain active NPA members, comply with all NPA supplier membership requirements, maintain compliance to the NPA GMP standards and terms of certification, pay an annual certification fee, and be re-audited every two years.
GMP Advisory Committee
To ensure appropriate and adequate ongoing oversight of the NPA GMP certification program, NPA established a GMP advisory committee that provides input on current program materials and activities. The GMP Advisory Committee, under the direct supervision of NPA, 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.
The functions of the Advisory Committee include:
- Periodic review of the NPA GMPs
- Review and revision of suggested programs, procedures and records, necessary to meet GMPs
- Review and revision of the Audit Checklist and Performance Rating System
- Selection of auditing companies and assessment of their performance
- Resolution of any disagreements between auditors and member suppliers
Third Party Auditors
Third-party auditors are utilized to conduct audits of supplier members according to established program audit protocol, utilizing the NPA GMP standards and audit documents. Auditors are selected by the Advisory Committee and approved by NPA, based on qualifications and prior experience conducting audits and inspections of food or dietary supplement manufacturers. Auditors must be trained in the NPA GMP standards and performance rating system, and have the required education, experience and training to conduct on-site audits. For more information about the NPA third-party auditors, see Third-Party Auditors for the NPA GMP Certification Program.
The purpose of the third-party audit is to verify a company's compliance with the requirements of the NPA 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 NPA 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 NPA for the final review and certification decision.
A member supplier has the ability to appeal audit finding or an assigned performance rating. The appeal must be in writing and must address each of the deficiencies and the reasons for the appeal. The written appeal must be submitted directly the GMP Advisory Committee c/o Natural Products Association along with the required fees.
For more detail about the on-site audit, compliance/performance rating, and appeal process please see the On-Site Inspections for the NPA Certification Program.