What is the history of current good manufacturing practices

The history of Current Good Manufacturing Practices (cGMP) dates back to the early 20th century in the United States. The first major event was the passage of the 1906 Food and Drugs Act, which required dangerous ingredients to be declared on product labels and prohibited adulterated and misbranded drugs[4]. This act led to the creation of the Bureau of Chemistry, which later became the Food and Drug Administration (FDA)[4].

In the 1920s, the FDA began to regulate the pharmaceutical industry more closely. The 1937 Elixir Sulfanilamide tragedy, which killed over 100 people, further emphasized the need for stricter regulations. This led to the development of more detailed guidelines for pharmaceutical manufacturing, including the creation of the Food, Drug and Insecticide Administration (FDIA) in 1937[4].

The modern cGMP regulations were formalized in 1969 with the publication of Part 128 of the Code of Federal Regulations (CFR). These regulations were later recodified as Part 110 in 1977. The FDA continued to refine these regulations over the years, including revisions in 1986 and ongoing efforts to modernize them in the 21st century[3][4].

The main objectives of cGMP are to ensure the quality and safety of products by controlling manufacturing processes, maintaining clean and hygienic facilities, and implementing quality control measures. The regulations have evolved to address specific industry needs and technological advancements, with a focus on preventing harm to consumers and patients[1][2].