Which regulatory body oversees GMP compliance in the USA?

The Food and Drug Administration (FDA) oversees Good Manufacturing Practice (GMP) compliance in the USA. The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. This includes establishing and enforcing regulations that govern the manufacturing processes for pharmaceutical products to ensure they meet required standards for quality and safety.

The FDA's involvement in GMP compliance is critical because it sets regulations that help manufacturers maintain consistency in their processes and products. This oversight helps prevent contamination, mix-ups, and errors that could compromise patient safety.

In contrast, the other organizations listed have different scopes of responsibility. The National Institutes of Health primarily focuses on biomedical research, while the Consumer Product Safety Commission deals with the safety of consumer products other than pharmaceuticals. The Environmental Protection Agency is concerned with environmental protection and regulations related to environmental health and safety rather than directly overseeing pharmaceutical manufacturing processes.