Beckers Nevus Clinical Quality Systems

Clinical quality systems are often managed independently of manufacturing and laboratory operations. This can result in a fractured view of each compliance area (GCP, GMP and GLP) and a failure to provide adequate oversight of an organization’s overall compliance. Using FDA’s six-system inspection model as a starting point, this article will discuss how to integrate the requirements of clinical quality systems with a GMP compliant quality program to provide a system for comprehensive quality oversight. The goals of a quality audit program are: to provide an accurate view of compliance across the organization, including suppliers and vendors; to identify and prevent or correct compliance issues; and to inform management of the compliance status of the organization. However, differences in the implementation of GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice) compliance programs may occur due to the different focus of each program.

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Last date updated on September, 2024