국내 제약사의 QbD 제도 도입에 대한 인식 및 현황 조사분석

Analysis of Perception and Status Survey on the Introduction of QbD System by Pharmaceutical Companies in Korea

The purpose of this study was to investigate and analyze the application status and system introduction perceptions of quality-by-design (QbD) in domestic pharmaceutical companies and confirm the necessity of introducing an effective QbD system. Currently, QbD-applied drug development is an international trend, and the introduction of QbD domestically is urgent because domestic pharmaceutical companies need QbD data even when exporting overseas. Therefore, 51 domestic pharmaceutical companies were surveyed to analyze their perceptions and opinions on the current status of QbD application and the introduction of the system. The results showed that most pharmaceutical companies, except 4.7% of total respondents, recognized the need for QbD for the following reasons: to improve the quality of medicines, responding to requests from overseas regulatory authorities when exporting products, problem-solving drug development and production, and proactively responding to the introduction of the QbD system by the Ministry of Food and Drug Safety. Although they are aware of its need, respondents are not implementing QbD due to cost and time issues and state that it is challenging to apply the QbD example in practice due to the method and amount of experimentation. Thus, the results of this study revealed that domestic pharmaceutical companies need QbD experimental and process guidelines and practical QbD examples. These results can be used as the foundation for the introduction and stable settlement of a domestic QbD system in the future.