1 回答
Health-Based Exposure Limits should be determined by a person who has adequate expertise and experience in toxicology/pharmacology, familiarity with pharmaceuticals as well as experience in the determination of health-based exposure limits such as Occupational Exposure Levels (OEL) or Permitted Daily Exposure (PDE).
HBEL应由具备足够专业知识并具有毒理学/药学经验、熟悉药物并具备基于健康暴露限确定经验如职业暴露水平(OEL)或允许日暴露量(PDE)的人员来确定。
Where experts are contracted to provide the HBEL, contractual agreements in compliance with Chapter 7 requirements should be in place prior to work being conducted. It is not considered acceptable for manufacturers to ‘purchase’ HBEL assessments without recording an assessment of the suitability of the provider (including the specific technical expert) as a qualified contractor.
如果使用合同专家来提供HBEL,则应在开始工作前依第7章的要求订立合同。不接受生产商在不记录数据提供者的(包括特定的技术专家)适当性认可其为合格分包商情况下直接“购买”HBEL评估。