Good Manufacturing Practices (GMP) Program
rev. 07/09

GMP Certified Companies

Program Objectives | Organization | GMP Advisory Committee | Third Party Auditors | On-site Audits | Performance Rating System | Appeal Procedure | Certification Procedure | Fees | Educational Events |

Program Objectives
The Natural Products Association GMP Certification Program is designed to verify compliance of member suppliers of dietary supplements with a standardized set of good manufacturing practices (GMPs) developed by the Natural Products Association. This program is based upon third party inspections of member suppliers and comprehensive audits of their GMP programs in the areas of Personnel, Plant and Grounds, Sanitation, Equipment, Quality Operations, Production and Process Controls, and Warehouse, Distribution, and Post-Distribution Practices. 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 purported quality.

Member suppliers that meet minimum Natural Products Association GMP standards and have received an "A" compliance rating after a Natural Products Association GMP audit will be entitled to apply for certification and use of the Natural Products Association GMP certification mark. The Natural Products Association certification and display of the GMP certification mark demonstrate to retailers, consumers and the public-at-large that products have been manufactured using good manufacturing practices and bring a means of self-assessment to the dietary supplement industry.

Organization - the Natural Products Association
The Natural Products Association, the largest dietary supplement trade association in the United States, has developed GMP standards based upon dialogs with member suppliers, other trade associations, and the FDA. The Natural Products Association GMPs are a living document and will be updated periodically based upon feedback from consultants, member companies, best quality practices and the FDA. The Natural Products Association will facilitate certification of member suppliers by providing education and training upon request.

GMP Advisory Committee
The GMP Advisory Committee, under the direct supervision of the Natural Products Association, is comprised of three experts selected for their expertise 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 Natural Products Association 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
Several agencies are selected to conduct audits of supplier members utilizing Natural Products Association GMPs and associated performance standards.

Auditing companies are selected by the Advisory Committee, based upon geographical location, resources, and prior experience conducting audits and inspections of food or dietary supplement manufacturers.

Auditing companies must be independent, with no known or potential conflict of interest, for each company for which they are contracted to complete an audit review. Auditors have agreed and been trained to conduct GMP audits only according to the audit checklist and performance rating system developed by the Natural Products Association.

Arrangements for initial audit, resolution of any findings, and any follow-up audits, are to be made jointly by the auditing company and the member supplier, but must follow the protocol developed by the Natural Products Association.

Auditing companies are limited to the determination of compliance of a member supplier to the Natural Products Association GMPs, and any decision with regard to certification is at the sole discretion of the Natural Products Association. It is a conflict of interest for an auditing company to currently consult with any member supplier for which it conducts an audit; or to have consulted with that member supplier for a three year period prior to the audit.

Auditing companies shall provide the Natural Products Association with copies of all audit and corrective action reports. They must also agree to the accompaniment of members of the Natural Products Association GMP Advisory Committee on a specified number of audits each year so that the Natural Products Association may assess the quality of audits and the need for revision of the audit checklist and/or performance rating system.

On-Site Audits
The purpose of the audit is to verify compliance of a member supplier's GMPs with the requirements of the Natural Products Association GMPs. It also provides for an exchange of information between the company and the auditor that will identify areas for improvement required to meet minimum the Natural Products Association GMP standards.

The member supplier must allow access to all facilities, which are involved with the manufacture, packaging, testing, and/or distribution of dietary supplements. The member supplier must also have a qualified representative available to answer the auditor's questions.

Audits will be conducted by experienced auditors that have been trained in the Natural Products Association GMPs and performance rating system, and have the required education, experience and training to conduct on-site audits. Typical education and experience of auditors is:

• A four year college degree in biology, chemistry, or food science
• Expertise in food or pharmaceutical GMPs
• Experience in the manufacturing processes for foods or dietary supplements
• Successful completion of training in the Natural Products Association GMPs

Auditors are responsible for all phases of the audits, including completion of the audit checklist, the audit report, follow-up on corrective actions, and any secondary audits.

A fee will be charged for the audit according to fee schedules submitted by the auditing companies. There will be additional charges to cover the auditor's travel and lodging expenses; these expenses are to be determined by the company and auditing company in advance of the audit.

Communication will occur directly between the auditing company and the member supplier during all aspects of the auditing process following guidelines developed by the Natural Products Association. Any disputes that cannot be resolved within these guidelines shall be referred to the GMP Advisory Committee for resolution.

Performance Rating System
The compliance ratings determine the need for corrective actions and follow-up inspections. Only member suppliers earning an "A" rating may immediately apply to the Natural Products Association for certification and the right to use the Natural Products Association GMP certification mark. A member supplier that lacks any of the mandatory elements during an audit will not receive an "A" rating, and therefore not be certified.

Member suppliers earning a "B" rating may apply to the Natural Products Association for certification and use of the certification mark once there is verification that corrective action towards outstanding deficiencies has been taken.

Member suppliers earning a "C" rating may apply to the Natural Products Association for certification and use of the certification mark after successful completion of a re-audit, and subsequent verification that outstanding deficiencies have been corrected. Supply members who do not earn an "A" rating on the first audit will have a stated time period to take the necessary corrective action. All documents and compliance rating scores related to GMP certification audits are confidential and securely maintained under the custody and control of the Natural Products Association's Scientific Affairs Department.

The levels of compliance are as follows:
A. A member supplier has excellent compliance with the Natural Products Association GMPs, with few deficiencies noted
B. A member supplier has good compliance with the Natural Products Association GMPs, but several significant deficiencies were noted
C. A member supplier has fair or poor compliance with the Natural Products Association GMPs, many deficiencies noted; a re-audit of the facility required

Appeal Procedure
A member supplier has the ability to appeal an assigned compliance 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 the Natural Products Association along with the required appeal fees.

The GMP Advisory Committee will review the appeal within 30 working days and attempt to resolve the issue through discussion with the member supplier and auditing company. If this is not possible, a site visitation will be arranged.

The Advisory Committee's review of any appeal is contingent upon prior payment of a fee to offset the expenses associated with appeal process.

Certification Procedure
Once a member company has documented compliance with Natural Products Association GMPs, they may apply to the Natural Products Association for certification and the right to use the GMP certification mark. The application will be reviewed together with the audit and corrective action reports. Upon successful completion of certification, the official Natural Products Association GMP certification mark may be used with member suppliers' marketing and advertisements. Certification will be valid for a period of no more than three years from the date of the award.

Note:To obtain certification, a member company must be audited under the Natural Products Association audit process described above. Compliance with other programs (e.g., ISO) will not be accepted as a substitute for the Natural Products Association audit process.

Fees
The certification program is self-funded through the assessment of fees for services rendered. Fees will be of three types:

1. Registration fees: $250.00 (includes program manual and referral to approved auditors).
2. Certification and use of certification mark fees: $1000.00, initial certification; $1000.00, annual maintenance. (Member suppliers will be assessed a fee to offset the cost of certification, including review of the application, the issuance of the certification and mark, and maintenance of the database)
3. Appeal fee: $500.00, with possibility of additional charges to cover any additional time or expenses incurred to resolve dispute.

An Advanced Course on the Final FDA GMP Rule for Dietary Supplements
In response to the final FDA GMP rule published on June 25, 2007, the Natural Products Association is offering a one and a half day educational seminar event to discuss the impact and provisions of the final rule. This important regulation establishes new mandatory requirements for dietary supplement manufacturers and dietary supplement distributors. Learn about what is expected and the consequences of non-compliance.

The Natural Products Association established the first GMP certification program for dietary supplements and has provided GMP education to the industry since 1999 through seminars and onsite training to over 500 companies.

2009 Seminars

An Advanced Course on the Final FDA GMP Rule for Dietary Supplements
(This is a one and a half day course)

• Expo East Boston, Mass. (September 23, 8 a.m.- 5 p.m. and September 24, 8 a.m. -noon)
  
• SupplySide West Las Vegas, Nev. (November 10, 8 a.m.- 5 p.m., and November 11, 8 a.m.- noon)

The course fee is $695 for association members and SupplySide West exhibitors, or $895 for non-members or non-exhibitors and includes a continental breakfast each morning and lunch on the first day. A 10-percent discount is available for multiple registrants from the same company.

Pre-registration deadline is 5 business days prior to the day of the seminar. Those who do not pre-register can register on site, space permitting, for an additional fee of $50.00 per attendee.

For more information or to register, contact Vicki Whitsitt at (800) 966-6632, ext. 243 or vwhitsitt@NaturalProductsAssoc.org.

You may also register by mail or fax using this form.