ABSTRACT
Current Good Manufacturing Practices were established to prevent drug and medical device manufacturers from producing and selling adulterated products to the public. In the United States, biopharmaceutical manufacturing compliance is based upon regulatory requirements for manufacturing processes and utilities, codified for human and animal drugs and in 21 code of Federal Regulations 210 and 211 as well as in other sections of Food and Drug Administration regulations. Importation of biopharmaceuticals is regulated by a number of agencies in every country of the world. Inspections provide one means of ensuring compliance and most countries have enacted laws to allow regulatory inspectors to review facilities, records, and operations that produce or distribute investigational or approved products. National interests and international political differences can be major hurdles to multinational regulatory approval of biotechnology products. There are many environmental hazards in biotechnology operations and there also are numerous federal, state, and local regulations as well as agencies to enforce them.
