摘要
目的介绍原料药(active pharmaceutical ingredient,API)中基因毒性杂质控制的法规要求、评估方法和控制方法。方法通过学习欧美法规发展历史,理解国际高端市场对基因毒性杂质控制的监管期望,提出原料药中基因毒性杂质风险评估方法。结果与结论企业基于半定量评估,结合清除研究数据,建立科学的控制策略,使实际工艺中所有可能涉及的基因毒性杂质风险得到明确鉴别和控制,是达到监管期望的有效途径。
OBJECTIVE To introduce the background of regulatory guidance, valuation and control strategy of genotoxic impurities in active pharmaceutical ingredient（API）. METHODS Based on the understanding of regulatory expectations on the control of genotoxic impurity by studying of the history of European and US regulations, propose methods for assessing ＆ controlling genotoxic impurities in drug substance. RESULT ＆ CONCLUSION The most effective way to achieve the regulatory expectations is to establish control strategies based on a combination of semi-quantitative assessment, allied to analytical results and data from appropriate purging studies. Such an approach should ensure that any actual genotoxic impurity related risk is clearly identified and managed.
出处
《中国现代应用药学》
CAS
CSCD
2015年第1期119-126,共8页
Chinese Journal of Modern Applied Pharmacy
