Quality Assurance for Worldwide Clinical Trials

Abstract

The emphasis on quality and integrity over the past 15 years has led to the continual development of new compliance inspection initiatives by the Food and Drug Administration (FDA). Recently, for example, the FDA enacted the approval inspection process, which requires the local FDA district office to address good manufacturing practices (GMP) requirements prior to approval of an application. The European Community (EC) also recently enacted good clinical practice (GCP) guidelines for clinical trials. The pharmaceutical industry must effectively address all these requirements regarding quality to meet its future needs. Corporate commitment plus an experienced staff; standard operating procedures (SOP), and a good documentation system are essential to meet global regulatory requirements.The integration of SOPs with a well-defined training program will assure corporate or contract research organization preparedness for clinical trial success. The research quality assurance function should be a valuable tool ...