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Good manufacturing practices (GMPs)
January 1999

Good manufacturing practices (GMPs) lie at the heart of quality. GMPs comprise a variety of practices that ensure quality including things such as:

  • raw materials quality assurance
  • record-keeping of substances throughout the manufacturing process
  • standards for cleanliness and safety
  • qualifications of manufacturing personnel
  • in-house testing
  • production and process controls
  • warehousing and distribution

GMPs: A more reliable means of achieving quality

GMPs provide quality assurances that off-the-shelf testing cannot. Off-the-shelf testing relies upon random sampling of a very small subset of the final product. Enormous resources must be expended to test one substance -- testing just a few samples of each brand. These tests provide only a snapshot-in-time view of a product's quality. Fluctuations in product quality are slow to be discovered via such after-the-fact testing.

In contrast, GMPs provide continual measures of quality that can uncover problems and fluctuations as they occur and before the product is shipped. Thus, GMPs are a more immediate and consistent way to control quality.

The need for GMPs takes on further importance because the issues involved in developing test methods for dietary supplements are many and complex. Until methods are further developed, standardized, and widely accepted, GMPs serve as a primary vehicle for ensuring quality.

Industry GMP standards

Virtually every manufacturer adheres to an in-house GMP standard, which varies from producer to producer. In-house GMPs, while often extremely effective, do not provide a means for outside verification of quality. In order to provide such verification, many are now embracing industry-standard GMPs which are usually subject to an independent outside audit for compliance.

A coalition of industry trade associations -- the Council for Responsible Nutrition (CRN), the National Nutritional Foods Association (NNFA), the American Herbal Products Association (AHPA), and the Consumer Healthcare Products Association (CHPA) -- developed a draft version of GMPs that they submitted to the FDA in 1995. The FDA subsequently published this GMP in 1997. They are not currently enforced.

The National Nutritional Foods Association (NNFA) ComPLI Committee, with their Advisory Board, developed a new GMP to a level deemed to be effective and appropriate. The NNFA GMP Certification Program was tested during 1998 and goes into effect in 1999. All NNFA supplier members will be required to comply with NNFA's GMP standards. Compliance entitles producers to inclusion of the NNFA GMP seal in product literature and on labels.

 

   
 

More about standards & regulations:

Industry standards

Creating a quality model for dietary supplements

Different types of standards

Pros and cons of standards

Competing standards

Testing products for quality

Dosage recommendations

Good manufacturing practices (GMPs)

Self-regulatory quality standards

Government regulations

FDA safety monitoring

Federal Trade Commision (FTC)

State laws

Health benefit claims

RDA, DV, and other recommended intake values

Funding of research at the National Institutes of Health (NIH)

Possible future FDA regulations

Possible future Codex regulations

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(c) Copyright 1999-2003 Dietary Supplement Quality Initiative. For permission to reprint, please contact our editor.