Good Manufacturing Practice: An Historical Overview and Actual Status

Abstract

The concept of good manufacturing practice (GMP) was based on the realization that the quality of pharmaceutical products cannot be controlled by end product testing alone, but also depends very much on the manufacturing process. Regulatory control of GMP began in 1938, when the United States introduced the Food, Drug and Cosmetic Act, which established registration controls and a factory inspection system. The phrase good manufacturing practice was first used in the 1962 Kefauver Harris amendment, but it was not until the 1970s and 1980s that GMP concepts really became the focus of regulatory attention in most countries. It is still the Food and Drug Administration (FDA), however, that sets the pace, and with its international inspection program, and the strict enforcement of GMPs, the FDA has made GMP a major issue in the pharmaceutical industry.

This strong focus on compliance, in an environment of increasing regulatory standards and highly sophisticated products and processes, demands a much higher level of organization for quality than in the past. In these circumstances, and particularly in the special environment of pharmaceutical development where some GMP measures may not be possible, quality management is indispensable.