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KMID : 1142220150100010063
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Regulatory Research on Food, Drug & Cosmetic
2015 Volume.10 No. 1 p.63 ~ p.73
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International Harmonization to Control Elemental Impurities in Pharmaceuticals: ICH Q3D Guideline
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Kim Eun-Kyung
Ji Jung-Eun
Park In-Sook
Kim Eun-Jeong
Lee Sun-Hee
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Abstract
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During the manufacturing process and/or storage of pharmaceuticals, impurities including organic impurities, residual solvents, and inorganic impurities could be introduced and/or remained. The International Conference on Harmonization (ICH) has provided the tripartite guidelines on related substances (organic impurities) and residual solvents in pharmaceuticals for international harmonization in quality control. However, it has not been harmonized to control elemental impurities till lately. Elemental impurities are mainly controlled by pharmacopoeia
requirements for heavy metals. However, most specifications and controls are not sufficient considered current science and technology. The need has been raised to control elemental impurities based on safety and risk. The ICH Q3D Expert Working Group has started to develop the guideline for elemental impurities since 2010. The draft guideline was open to public for regional regulatory consultation in 2013, and the final harmonized guideline for elemental impurities has been provided in 2014. This new ICH guideline, Q3D, suggests safetybased limits for 24 elements with toxicological concern and risk-based approach to ensure control for them in drug products. The scope of the guideline includes new finished drug products (as defined in ICH Q6A and Q6B) and new drug products containing existing drug substances. The guideline will be applied to existing products 36 months later after publication of the guideline. To facilitate implementation, training packages are being developed by the Implementation Working Group. The Ministry of Food and Drug Safety (MFDS) has participated in the Q3D Expert Working Group to be involved in developing the guideline. The participation has given MFDS chances to reflect Korea’s opinions and to discuss about issues. International activities on the Q3D guideline could contribute to international harmonization in quality control of pharmaceuticals. Through the international cooperation, it is expected to raise effectiveness and efficiency in implementation of this guideline in Korea, which will also contribute to enhanced quality control system in Korea.
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KEYWORD
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International Conference on Harmonization (ICH), Heavy metal, Elemental impurities, Permitted daily exposure (PDE), Risk assessment
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