Good Manufacturing Practices – What Do They Mean, Why Are They Important? – Informed Opinion

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By Marcia Zimmerman, CN, February 2013.  The Good Manufacturing Practices (GMP) seal on supplement bottles identifies supplements that adhere to a high set of manufacturing standards. Posted February 19, 2013.

Good Manufacturing Practices

You may be familiar with the GMP seal on supplement bottles. What you may not know is how use of this seal became an important milestone for the natural foods industry and how it identifies supplements that adhere to a high set of standards.

In the early days of the dietary supplement industry, it became apparent that a set of standards for products needed to be in place.  Toward that end, retailers, suppliers and distributors formed a natural foods organization in 1938. (1)  Through a series of name changes, the organization became the Natural Products Association (NPA). But it took until 1971 for the organization, at that time called the National Nutritional Foods Association (NNFA), to formally set up a “standards” committee. (2)

One of the primary functions of NPA has always been to maintain a set of standards for natural foods and dietary supplements. It has been a task regularly challenged through the years by the Food and Drug Administration. The industry fought to establish a “self-policing” policy to ensure that dietary supplements meet the highest standards of quality and purity. The result is Good Manufacturing Practice or GMP. Only the best companies in the industry bear the GMP seal.

In order to display the GMP seal on its label, a product must meet a stringent set of criteria including plant maintenance, manufacturing practices, equipment, qualifications of personnel, ingredient sourcing, production, and bottling, testing, shipping, and sample retention for future testing.  Independent third party audits are conducted for all products that bear the GMP seal.

FDA used industry GMPs and model regulations from the pharmaceutical industry in drafting their cGMPs which have been in effect since July 08, 2010. CGMPs set the bar for the manufacture of dietary supplements even higher. The cGMPs requires that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards. They apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S. (3)  Complying with cGMPs involves not only the manufacturing company but all of its suppliers who must also be cGMP compliant.  FDA auditors conduct the inspections which may take several days and are extremely rigorous. The published inspectional directive that auditors follow is not all inclusive. A return audit of a compliant manufacturer may highlight new requirements of the dietary supplement GMPs. (4)

On-site inspections include:(5)

  • Employ qualified employees and supervisors
  • Design and construct physical plants in a manner that protects dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, labeling and holding.
  • Use equipment and utensils that are of appropriate design, construction, and workmanship to the intended use
  • Establish and use master manufacturing and batch production records.
  • Establish procedures for quality control operations.
  • Hold and distribute dietary supplements and materials used to manufacture dietary supplements under appropriate conditions of temperature, humidity, light, and sanitation so that the quality of the dietary supplement is not affected. 
  • Keep a written record of each product complaint related to cGMPs.
  • Retain batch records for 1 year past the shelf life date.
  • Testing of final product or incoming and in process materials

FDA does not use a seal to identify those companies that are in compliance because ongoing inspections may utilize a newly defined set of criteria and because an inspector’s interpretation may differ from that of former inspectors. The closest a manufacturer can come to attesting to quality, purity and GMP compliance is to meet the auditing “check list” of the NPA, National Science Foundation (NSF), or United States Pharmacopeia (USP), and display the appropriate seal on labels. The audits of these three organizations do not completely match those of FDA.  However, the GMP, NSF or USP seals that appear on supplement labels gives the consumer assurance that the manufacturer is one who adheres to the highest standards for quality and purity. The top supplement companies display one of these seals. Companies that do not conform cannot display such seals on their product labels or in advertising.

The natural products industry has gone a long way towards achieving standards for product quality and integrity since the early days of its inception.  It is important to recognize what GMPs mean and how that distinguishes quality products from those that are lacking.

References:

  1. Murray, F.; More Than One Slingshot: How the Health Food Industry is Changing America Richmond, VA Marlborough House 1984.
  2. Richard, D.; Beating the Odds Richfield, CT Vital Health, 2002 p. 28.
  3. Federal Register, Food and Drug Administration, 21 CRF Part 111 (Docket No. 1996N-0417) FDA “Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts” June 22, 2007.
  4. FDA; “Dietary Supplements-Import and Domestic (Implementation Date: 03/26/2010) includes Pen & Ink Changes as of 07/08/10 to Parts I and II.” Chapter 21- Food Composition, Standards, Labeling, and Economics. 
  5. FDA “Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts” June 22, 2007