Quality-assurance activities are an absolute necessity in the pharmacy. Each aspect of pharmacy requires quality measurements to ensure integrity of the process and the final product. Crucial to any product that is manufactured, including sterile compounds, and delivered to a patient population is a set of testing activities that determine the integrity of both the production process and the quality of the final product. Through careful design and validation of both the process and process controls, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Pharmacy is a highly regulated arena. Sterile product preparation, if conducted poorly, has the potential for producing contaminated products that can harm patients and personnel. Problems due to cross-contamination, such as infection and even death, can result if strict procedures that limit the possibility of such exposure are not followed.