Good Manufacturing Practices (GMP)

What is GMP?

Good manufacturing practice is a system for ensuring that medicinal products are consistently produced and controlled according to quality standards. These standards are established by the government agencies to facilitate safe manufacturing of drug products. The standards are designed to minimize the risks involved in the manufacturing of pharmaceutical products. Globally, three bodies monitor GMP. These are the United States Food and Drug Administration, the European Union, and the World Health Organization.

The FDA is part of the “Code of Federal Regulations, or CFR. The Code of Federal Regulations is the official legal print publication containing the codification of the general rules published in the Federal Register by the agencies of the Federal Government. It is divided into 50 different titles that represent different sections regulated by the Federal government. The Drug Quality regulations are defined in the title 21, which is further divided into chapters, sub-chapters, and parts. For example, the regulations related to electronic records and electronic signatures are defined in the chapter 1, subchapter A, and part 11. This can be shortly denoted as 21 CFR Part 11.