국내 제약사의 QbD 제도 도입에 대한 인식 및 현황 조사분석

The purpose of this study was to investigate and analyze the application status and system introductionperceptions of quality-by-design (QbD) in domestic pharmaceutical companies and confirm the necessity of introducing aneffective QbD system. Currently, QbD-applied drug development is an international trend, and the introduction of QbDdomestically 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 currentstatus 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 ofmedicines, responding to requests from overseas regulatory authorities when exporting products, problem-solving drugdevelopment and production, and proactively responding to the introduction of the QbD system by the Ministry of Foodand Drug Safety. Although they are aware of its need, respondents are not implementing QbD due to cost and time issuesand 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 processguidelines and practical QbD examples. These results can be used as the foundation for the introduction and stablesettlement of a domestic QbD system in the future. KCI Citation Count: 0