ABSTRACT
Cleaning pharmaceutical equipment and facilities has a direct impact on the quality of the products, and thus is closely associated with compliance. Most of the manufacturing of pharmaceutical products in the United States and other developed countries is accomplished using multiuse equipment; that is, the same equipment is used to manufacture several different products. Because of this, there is ample opportunity for the cross-contamination between one product and the subsequently manufactured product. Even for products manufactured in dedicated equipment, contamination is possible by environmental and microbiological contaminants. The current good manufacturing practices regulations [1, 2] require that products be made using clean equipment and facilities. Since cleaning is generally regarded as a critical step in the manufacturing process, the potential compliance issues associated with cleaning are multifold and very important to the manufacture of high-quality and safe pharmaceutical products. This chapter will be devoted to the identification and discussion of some of the specific compliance issues associated with cleaning in pharmaceutical facilities.
