Which agency is primarily responsible for verifying CGMP compliance at outsourcing facilities?

Which agency is primarily responsible for verifying CGMP compliance at outsourcing facilities?

• A. CBP
• B. FTC
• C. FDA
• D. EPA

Answer: (C)

The main idea is identifying who enforces the quality standards for drug manufacturing. Current Good Manufacturing Practice regulations are established and enforced by the FDA, which oversees drug safety and quality. Outsourcing facilities—contract manufacturers that produce drug products—must register with the FDA and are subject to FDA inspections to verify CGMP compliance. If violations are found, the FDA has enforcement tools to address them. Other agencies—CBP handles import/export at the border, FTC focuses on consumer protection and competition, and EPA covers environmental rules—do not verify CGMP compliance for drug manufacturing. Therefore, the FDA is the responsible agency.

The main idea is identifying who enforces the quality standards for drug manufacturing. Current Good Manufacturing Practice regulations are established and enforced by the FDA, which oversees drug safety and quality. Outsourcing facilities—contract manufacturers that produce drug products—must register with the FDA and are subject to FDA inspections to verify CGMP compliance. If violations are found, the FDA has enforcement tools to address them. Other agencies—CBP handles import/export at the border, FTC focuses on consumer protection and competition, and EPA covers environmental rules—do not verify CGMP compliance for drug manufacturing. Therefore, the FDA is the responsible agency.