"Current Good Manufacturing Practices" and the Federal Food, Drug and Cosmetic Act

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"Current Good Manufacturing Practices" and the Federal Food, Drug and Cosmetic Act

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Title: "Current Good Manufacturing Practices" and the Federal Food, Drug and Cosmetic Act
Author: Goldstein, Beth F.
Citation: "Current Good Manufacturing Practices" and the Federal Food, Drug and Cosmetic Act (1995 Third Year Paper)
Full Text & Related Files:
Abstract: The Food and Drug Administration (hereinafter, FDA) regulates food, drugs, and cosmetics in order to ensure that these products are safe and truthfully labelled. As part of its responsibilities under the Federal Food, Drug, and Cosmetic Act (hereinafter, Act), the FDA monitors the manufacturing practices of companies involved in the production of food, drugs, and medical devices. The manufacturing practices used by these companies must comply with certain standards, identified in the Act as "current good manufacturing practices" (hereinafter, CGMP). If a company's practices do not conform with CGMPs, the finished products are considered adulterated, even if the products are technically perfect. The purpose of CGMPs is to assure the safety and efficacy of the finished products.
Terms of Use: This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAA
Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:10018980

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