ICH Q3D元素杂质主要内容.pdfVIP

ICH Q3D 主要内容 1. INTRODUCTION 2. SCOPE 3. SAFETY ASSESSMENT OF POTENTIAL ELEMENTAL IMPURITIES 主要讲PDE 是怎么出来的 4. ELEMENT CLASSIFICATION The elements included in this guideline have been placed into three classes based on their toxicity (PDE) and likelihood of occurrence in the drug product. The likelihood of occurrence is derived from several factors including: probability of use in pharmaceutical processes, probability of being a co-isolated impurity with other elemental impurities in materials used in pharmaceutical processes, and the observed natural abundance and environmental distribution of the element. For the purposes of this guideline, an element with low natural abundance refers to an element with a reported natural abundance of 1 atom/106 atoms of silicon (Ref. 5). The G classification scheme is intended to focus the risk assessment on those elements that are the most toxic but also have a reasonable probability of inclusion in the drug product (see Table 5.1). The elemental impurity classes are: R A.基于两点给元素杂质分类：1，毒性（PDE ）；2 ，在药品中出现的可能性。 B.评估可能性从三个方面：1.工艺过程中使用；2.在工艺过程使用的元素带入的。 3.元素在自然界环境中分布 9 C.综合评估分类的两种因素来确定在风险评估中分析哪些元素。 2 Class 1: The elements, As, Cd, Hg, and Pb, are human toxicants that have limited or no use in the manufacture of pharmaceuticals. Their presence in drug products typically comes from commonly used materials (e.g., mined excipients). Because of their unique nature, these four elements require evaluation during the risk assessment, across all potential sources of elemental impurities and routes of administration. The outcome of the risk assessment will determine those components that may require additional controls which may in some cases