Merging GCP and ISO 9000 Requirements—A Source of Synergy in Quality Management of Clinical Research

Abstract

The European Community (EC) good clinical practice (GCP) guidelines require that “A System of Quality Assurance … must be employed and operated by the sponsor.” The guidelines themselves detail the requirements for the conduct of clinical studies to GCP standards. In order to fit these requirements into a wider quality management framework, it is important to place the GCP requirements alongside another set of criteria that specify the needs of a quality management system. The ISO 9000 “Quality management and quality assurance standards” (1) provide a framework of requirements for a quality management system that complements and supports the GCP guideline. This paper describes how the ISO 9001 requirements apply to GCP. This is done through examples of GCP-related issues that fall under each of the ISO 9001 headings. An overview of all the headings is given and then three are examined in more detail: contract review, document control, and corrective action.