It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle. 它专门为质量风险管理的原则和一些工具提供指导,这些工具可以使监管机构和行业能够在整个产品生命周期中就活性成分和药物(药用)产品的质量做出更有效和一致的基于风险的决策。--ICH Q9 《风险管理》
It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle.