FDA 21 CFR Part 210 and 211

FDA 21 CFR Parts 210 and 211 are regulations that govern the manufacturing and quality control of pharmaceuticals in the United States. Part 210 outlines the current good manufacturing practices (cGMP) to ensure the safety and quality of drug products. Part 211 provides specific requirements for manufacturing processes, quality assurance, and record-keeping. Together, these regulations help ensure that medications are produced consistently, safely, and with high standards, protecting public health by reducing risks of contamination, mix-ups, and errors during production. Compliance is critical for pharmaceutical companies to maintain trust and efficacy in their products.