21 CFR Part 210 and 211

21 CFR Part 210 and Part 211 are regulations set by the U.S. Food and Drug Administration (FDA) governing the manufacturing of drugs. Part 210 outlines the basics of good manufacturing practices (GMP), emphasizing the need for a consistent process to ensure product quality. Part 211 provides detailed requirements for drug production, including facilities, equipment, and record-keeping. Together, these regulations ensure that drugs are produced safely, effectively, and according to established standards, ultimately protecting public health by ensuring that pharmaceuticals are reliable and free from contamination or defects.