ABSTRACT
INTRODUCTION Under the Food, Drug, and Cosmetic Act, a drug is deemed to be adulterated unless the methods used in its manufacture, processing, packaging, holding, and the utilized facilities and controls, conform to current Good Manufacturing Practices (cGMP). These require the drug to meet the safety requirements of the Act, contain the proper strength and identity, and meet the quality and purity characteristics that it is represented to have. A properly designed and constructed manufacturing facility and its associated utilities support these practices.
