Good Manufacturing Practices
You may have seen the GMP seal on supplement bottles, but most people are unaware of what exactly the acronym stands for – Good Manufacturing Practices- and if they do, may not understand what exactly Good Manufacturing Practices are or what kinds of regulations are in place for certification. The GMP seal is actually an important milestone for the natural foods industry and 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. That organization (several name changes later) 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.
One of the primary functions of NPA has always been to maintain a set of standards for natural foods and dietary supplements. 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.
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.
In July 2010 the FDA used industry GMPs and model regulations from the pharmaceutical industry to draft their cGMPs. 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.
On-site inspections include:
- 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
When you see a GMP seal on a supplement label you have the assurance that the manufacturer is one who adheres to the highest standards for quality and purity. Companies that do not conform cannot display such seals on their product labels or in advertising.
Further reading: NPA GMP Certification Program Overview