Good Manufacturing Practices

The Quest For Quality

Consumers look for quality assurances when they are purchasing products.  Sadly, there are few indicators to help them sort through aggressive advertising claims and promotional packaging.  There was a time when consumers could look for the Good Housekeeping Seal of Approval, but the seal seems to have gone the way of  “Father Knows Best” and “Ozzie and Harriet.”  Consumers still buy Consumer Reports and evaluate product research before they make major purchases of cars and electronic equipment, but that’s often the full extent of quality assurance. 

Good Manufacturing Practices are the result of NNFA’s goal of assuring the public of supplement safety and reliability.  To meet this goal, NNFA has established a Good Manufacturing Practices (GMP) Certification program.  The program is designed to ensure that all stages of the manufacturing process meet strict standards for safety and quality.  Once a company is certified, it may use NNFA’s distinctive GMP Certification seal in their advertising and marketing of their products. 

The way a company achieves GMP certification is by successfully passing an inspection by third-party auditors.  The program works very much like hospital accreditation, where the facility and service practices must meet certain industry standards.   The facility inspections are very comprehensive and the cover performance standards in areas of personnel, sanitation, quality operations, production and process controls, as well as warehouse and distribution practices.  Once a company has been shown to be in compliance with NNFA GMPs, it may apply to the association for certification.  The certification is valid for three years, at which time a new audit and on-site inspection is required.

NNFA is actively supporting and assisting manufacturers in determining their readiness for inspection.  They are offering training seminars and support materials, including a self-assessment.   Manufacturers can use this tool to evaluate their current practices. 

NNFA developed it GMPs based on dialogues with member suppliers, other trades associations, and the FDA.  Compliance with NNFA GMPs is a requirement of membership for suppliers beginning in 1999, with a 3-year implementation allowance.   The written standards are considered a “living document” and will be updated periodically, based on feedback from consultants, member companies, best quality practices and the FDA.

NNFA uses an advisory committee to select the third-party auditors.  The advisory committee is comprised of three experts who were selected for their expertise and training in GMPs.  NNFA strives to select members who have a diverse background in food, dietary supplements, pharmaceuticals and botanicals.

The purpose of the audits is to determine compliance with established GMPs and to identify areas for any improvement required to meet the GMPs.  NNFA is using a three-level performance rating system.  The levels of compliance are as follows:

A member supplier has excellent compliance with NNFA GMPs; no major deficiencies are noted.

A member supplier has good compliance with NNFA GMPs; only a few major or minor deficiencies are noted.

A member supplier has fair or poor compliance with NNFA GMPs; many major deficiencies are noted.

The compliance ratings are used to determine the need for corrective actions and follow-up inspections.

The certification program is self-funded through the assessment of fees.  The fees include a registration fee, a certification and use of seal fee (one for initial certification and one for annual maintenance). 

The need to establish GMPs arose from passage of the Dietary Supplement health and Education Act (DSHEA).  One provision of DSHEA was that “ The Secretary may by regulation prescribe good manufacturing practices (GMP) for dietary supplements.”   In response, industry members took a proactive step and met with the FDA in 1995 and they submitted a document that outlined proposed GMP for dietary supplements.  The objectives of the GMPs, as stated by the industry representatives, were to ensure that consumers were provided with quality assured dietary supplements.   The GMPs were modeled after the GMPs for foods.  The FDA responded by publishing the suggested dietary supplements GMPs in the Federal Register and soliciting comments from industry, consumers, and other interested parties. 

DSHEA opened up many new opportunities for the industry.   Good Manufacturing Practices are one of these opportunities. Implementing GMP certification clearly will require a commitment of both time and money, but this investment in quality should be returned many-fold as increased confidence from retailers, consumers and, most particularly, the FDA.