Survey of risk-based quality management status and establishment of operational model in clinical trials

Abstract

Purpose: With the release of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use E6 addendum, it is very important to establish risk-based quality management systems which meet good clinical prac-tice. The aim of this research was to propose for risk-based quality management practices in the organizations that conduct clinical trials in South Korea. Materials and Methods: The survey participant pool consisted of domestic or multinational pharmaceutical companies and full-service clinical research organizations operating in South Korea that had one or more clinical trials approved by the Korean Ministry of Food and Drug Safety in 2018. Results: Of the 97 selected companies, a total of 61 companies completed the survey. A total of 42 companies (68.9%) had employ-ees designated to quality management activities. The minimum and maximum numbers of dedicated personnel for quality management were one and 12, respectively, and the average was three. Regarding the role of quality management personnel in compa-nies, standard operating procedure management, issue/corrective action and preventive action (CAPA) management, and preparing inspection were selected the most (81%). The system considered to be the most important for risk management was monitoring system (41 companies, 67.2%), followed by both vendor management and CAPA management systems (17 companies, 27.9%). Conclusion: In the future, organizations conducting clinical and subsequent pilot studies trials in South Korea should follow these quality management practice to share information with each other.