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KMID : 1142220180130020085
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 2 p.85 ~ p.97
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Quality by Design (QbD): Application of Risk Assessment
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Ha Eun-Sol
Sim Woo-Yong
Park Sung-Min
Shin Sang-Mun
Jeong Seong-Hoon
Hwang Sung-Joo
Choi Du-Hyung
Kim Min-Soo
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Abstract
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Based on the Good Manufacturing Practice (GMP), there is growing interest in the quality by design (QbD) system, which can integrate and manage the processes from product development to manufacturing process. In recent years, advanced countries such as US / EU have been using the QbD system for the production of drugs. The introduction of the QbD system requires a systematic and scientific understanding of the manufacturing process for drug manufacturing and quality management systems. In order to achieve QbD, implementing risk assessment and building design space is required. In this study, we prepared quantitative risk assessment data using failure modes and effects analysis (FMEA) based on the example model data published by the U.S. FDA. Also, we have derived what needs to be identified and reviewed when using FMEA as a risk assessment tool. Through these results, we intended to help understand how to perform a risk assessment in detail.
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KEYWORD
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Risk assessment, Quality by design (QbD), Failure Modes Effects Analysis (FMEA), Good Manufacturing Practice (GMP)
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