The use of total quality principles to achieve regulatory compliance in research laboratories.
Since the late 1980s, the U.S. Food and Drug Administration (FDA) has increased its focus on regulatory compliance. This is evidenced by an increase in warning letters, product seizures, injunctions, prosecutions, and recalls. This increased level of FDA enforcement activity is evidenced across all of the compliance regulations. Thus, the ability to comply with the Good Laboratory Practices (GLPs). Good Clinical Practices (GCPs) and Good Manufacturing Practices regulations could result in FDA enforcement activities and delays in the approval process for new products. Therefore, the ability to achieve compliance with the GLPs, GCPs, and GMPs in research laboratories is a key to business success in the 1990s. Applying the principles of total quality is one way to address these important business issues. The principles of total quality (customer focus, improvement, involvement, leadership, and measurement) provide a methodology for ensuring success in a rapidly changing regulatory environment. The FDA needs to be treated as a customer by research organizations. Valid regulatory requirements need to be negotiated with the agency. Once these customer requirements have been identified, the quality unit needs to play a leadership role in translating these requirements into action plans. Quality units, no matter how skillful or good, cannot achieve success without involvement of the scientific staff and management group of their organizations. Without their involvement there will be no organizational commitment to compliance programs undertaken to meet the valid requirements of the FDA. Meeting these valid customer requirements will require improvement efforts. The many tools of quality improvement in achieving the desired improvements.(ABSTRACT TRUNCATED AT 250 WORDS)
Hynes
M D
MD
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA.
D002986:Clinical Trials as Topic / Q000592:standards; D004345:Drug Industry / Q000592:standards*; D005161:Facility Regulation and Control; D005568:Forms and Records Control / Q000592:standards; D007373:Interinstitutional Relations; D007753:Laboratories / Q000592:standards*; D007857:Leadership; D009936:Organizational Innovation; D011786:Quality Control; D012106:Research / Q000592:standards; D017749:Total Quality Management; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*