Good Manufacturing Practices (GMPs) – An Overview

Authored by: Ira R. Berry

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:

10.1081/E-EPT4-v3-16

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Abstract

The Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals that have been promulgated by the U.S. Food and Drug Administration (FDA) have been a subject of active discussion since they were first published with the passage of the Kefauver-Harris Drug Amendments in 1962 (1,2). GMPs were intended to establish minimum manufacturing and control practices for the pharmaceutical industry and focus on what needed to be done rather than how it should be done. Failure to comply with the current GMP regulations as set forth in the “Code of Federal Regulations,” 21 CFR Parts 210 and 211, (3), constitutes adulteration of a drug that is entered into interstate commerce and is therefore subject to regulatory action. These requirements apply to human and animal drugs. The regulations in Part 210 are introductory in nature; Part 211 contains the more detailed and descriptive regulations and will be discussed in this chapter.

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