The Food and Drug Administration has published new Current Good Manufacturing Practices (CGMPs) regulations for dietary supplements. These regulations will affect any manufacturers of dietary supplements who sell product in the United States.
The final CGMPs are effective in June 2008 for large companies, but companies with less than 500 employees have until June 2009, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.
According to the new regulations, manufacturers must establish and use master manufacturing and batch production records; establish procedures for quality control operations; and keep a written record of each product complaint related to CGMPs.
Under the CGMP rule, manufacturers are also required:
to employ qualified employees and supervisors;design and construct their physical plant in a manner to protect 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 for 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;and retain records for one year past the shelf life date, if shelf life dating is used, or two years beyond the date of distribution of the last batch of dietary supplements associated with those records.
Probably the biggest change is the requirement to have written procedures for all the quality critical processes in their manufacturing operations. Also of interest is what FDA did NOT do. They did not require the Dietary Supplement makers to validate their manufacturing processes. FDA did, however, require that Dietary Supplement manufacturers use scientifically valid analytical methods to test their final products.
The Dietary Supplement Health and Education Act (DSHEA) has been in existence since 1994. Under DSHEA, manufacturers have a responsibility to substantiate the safety of their products and determine that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading.
The new, final CGMPs will help to ensure manufacturers produce unadulterated and properly labeled dietary supplements in order to protect consumers. Consumers will in turn have access to dietary supplements that meet quality standards and that are free from contamination and are accurately labeled, which will give consumers greater confidence that the dietary supplement they use has been manufactured to ensure its identity, purity, strength, and composition.
Examples of product quality problems that the rule will help prevent are: dietary supplements that contain ingredients in amounts that are greater than those listed on the label; dietary supplements that contain ingredients in amounts that are less than those listed on the label; wrong ingredients; other contaminant (e.g., bacteria, pesticide, glass, lead); foreign material in a dietary supplement container; improper packaging; and mislabeling.
The interim final rule does allow manufacturers to petition FDA for an exemption from the requirement of 100 percent identity testing of one or more dietary ingredients used in manufacturing the dietary supplement. The manufacturer would provide data to demonstrate that its proposed reduced frequency of identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient. Each petition will be considered on a case by case basis.
The new CGMPs are key in bolstering consumer confidence regarding dietary supplements, an industry that at times has been looked at unfavorably in recent years. For more information on the new CGMP regulations, go here: http://www.cfsan.fda.gov/~dms/dscgmps6.html
Copyright: Copyright © 2008 Norm Howe
About the Author:
| Norm Howe, Senior Partner at Validation and Compliance Institute, consultants for the pharmaceutical and medical device industries. He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA. He has held many management positions in FDA regulated industries, most at BASF. http://www.vcillc.com
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