Program Objectives
The NNFA 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 NNFA. 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 NNFA GMPs standards and have received
an "A" compliance rating after an NNFA GMP audit will be entitled to
apply for certification and use of the NNFA GMP certification mark. NNFA
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 - NNFA
The NNFA, 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 NNFA GMPs are a
living document and will be updated periodically based upon feedback
from consultants, member companies, best quality practices and the FDA.
NNFA 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 NNFA, 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 the NNFA 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 the NNFA 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 NNFA.
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 NNFA.
Auditing companies are limited to the determination of compliance of
a member supplier to NNFA GMPs, and any decision with regard to
certification is at the sole discretion of NNFA. 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 NNFA with copies of all audit and
corrective action reports. They must also agree to the accompaniment of
members of the NNFA GMP Advisory Committee on a specified number of
audits each year so that the NNFA 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 NNFA 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 NNFA 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 NNFA 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 NNFA 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.
Performance Rating System
The levels of compliance are as follows:
A. A member supplier has excellent compliance with NNFA GMPs, with few
deficiencies noted
B. A member supplier has good compliance with NNFA GMPs, but several
significant deficiencies were noted
C. A member supplier has fair or poor compliance with NNFA GMPs, many
deficiencies noted; a re-audit of the facility required
The compliance ratings determine need for corrective actions and
follow-up inspections.
Member suppliers earning an "A" rating may immediately apply to NNFA for
certification and the right to use the NNFA GMP certification mark.
Member suppliers earning a "B" rating may apply to NNFA for
certification and use of the certification mark once there is written
verification that the outstanding deficiencies have been corrected.
Member suppliers earning a "C" rating may apply to the NNFA for
certification and use of the certification mark after successful
completion of a second audit and once there is written verification that
outstanding deficiencies have been corrected.
Certification Procedure
Once a member company has documented compliance with NNFA GMPs, they may
apply to NNFA 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 NNFA GMP certification mark may be used on
the member supplier's labels, 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 NNFA audit process described above. Compliance with other programs
(e.g., ISO) will not be accepted as a substitute for the NNFA audit
process. |
