EMA 交叉污染和共用设施暴露限度指南问答-2018（中英文对照版）.pdf

19 April 2018 EMA/CHMP/CVMP/SWP/246844/2018 Committee for Medicinal Products for Veterinary Use (CVMP) Committee for Medicinal Products for Human Use (CHMP) Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012) 基于风险防止药品生产中交叉污染以及 “共用设施中不同药品生产风险识别所用基于健康的暴露限设定指南” 实施问答 翻译： 流浪的沙子 校对： Owen GMP 办公室组织翻译 GMP 办公室 • 专业的 GMP 合规性研究组织 • 国内外（FDA、 EMA、 MHRA、 CFDA、 WHO 、 PIC/S 等） GMP 法规解读； • 国内外制药行业 GMP 监管动态； • GMP 技术指南（ISPE、 PDA、 ISO、 ASTM 等）分享 官方微信公众号： EMA/CHMP/CVMP/SWP/246844/2018 1/8 GMP 办公室翻译组 Q1. Are Health-Based Exposure Limits (HBELs) required for all medicinal products? 是否所有药品都需要基于健康的暴露限度（HBEL）？ A: Yes, HBELs should be established for all medicinal products. The toxicological or pharmacological data, on which the HBEL calculation relies, requires periodical reassessment throughout a product’s lifecycle. 是的，所有药品都需要建立HBEL。用于计算HBEL 的毒理或药理数据需要在药品生命 周期中定期评估。 Q2. Is there a framework that could be used to define the significance of the Health-Based Exposure Limit (HBEL) such that there can be broad guidance on the extent of Quality Risk Management (QRM) and control measures required? 是否有一个框架定义基于健康的暴露限度（HBEL）的重要性，例如一个关于质量风险 管理（QRM）和相应控制措施的程度的指导？ A: Firstly, it should be recognised that hazard varies on a continuum scale and that there are no firm cut off points, risk should be controlled on a proportionate basis. However, as a broad hypothetical model the following figure could be considered to show the increasing level of hazard (red being highest hazard) presented by products and there should be a commensurate increase in the level of control