The Food and Drug Administration (FDA) in the United States has official restrictions on the design, monitoring, control, and maintenance of manufacturing processes and facilities. These regulations are known as Current Good Manufacturing Practices, or cGMPs. Companies in the pharmaceutical and biotechnology industries adhere to cGMPs to guarantee that their goods fulfill a number of specifications, such as strength, quality, purity, and features. The FDA regulates compliance. There are numerous federal laws pertaining to cGMP, and breaking them might result in legal repercussions.
The collection of all federal regulations, both permanent and general, is known as the Code of Federal Regulations (CFR). The complete and official wording of all regulations that are upheld by federal agencies is found in the CFR. Title 21 of the CFR, which contains the FDA's part, provides an explanation of the federal food, drug, and cosmetic act as well as other regulations, such as the public health services act. Title 21 has many sections including laws pertaining to pharmaceutical or medication quality.
