ICH Q3D施行與風險評估   全文下載

Implementation and Risk Assessment of ICH Q3D

藥品中元素不純物（Elemental Impurities, EI）需要管控，相關規範指引ICH Q3D於2019年三月定稿，臺灣於2018年公告採用ICH更新清單時納入Q3D指引。本文主要探討Q3D之起源、目的與其施行之重點，並引用國際間普遍作法敘明風險評估之執行要點。其程序包括應評估不純物毒性數據與可能之潛在來源，確立各個元素每日允許暴露量（Permitted Daily Exposure, PDE），依據投藥途徑、每日服用劑量與PDE值，運用合適的方法設定元素不純物允許濃度限量，最終做成風險評估報告。並視各元素不純物濃度是否超過30%的PDE閾值（或PDE值），確立藥品是否需對某些元素進行額外的管控，以保證藥品品質。

Elemental impurities (EIs) in drug products can come from several sources, the relevant guideline ICH Q3D was finalized in March 2019. Taiwan Food and Drug Administration announced to adopt the updated ICH list in 2018, which included the Q3D guideline. This article mainly discusses the origin, purpose and focus of implementation of Q3D, and cites common international practice for risk assessment. The risk assessment of element impurities should consider the evaluation of the toxicity data for potential elemental impurities, the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern, and application of a risk-based approach to control elemental impurities in drug products. Depending on whether any elemental impurity in drug products exceeds 30% of the PDE threshold (or exceeds the PDE value), determine whether it requires additional control of certain elements to ensure the quality of the drug products.