用合理的质量量度指标助力药品质量的科学监管

Using Reasonable Quality Metrics for the Scientific Supervision of Drug Quality

目的:解读美国食品药品监督管理局(FDA)提出的质量量度相关指南内容,为国内药品生产企业和监管部门的质量管理提供参考。方法:本文通过回顾和介绍质量量度指南草案的发展和内容,对比两版指南草案内容的异同点,梳理和解读其内涵,探讨质量量度指标在企业应用的可行性和适用性。结果和结论:FDA的质量量度相关指南,提出了客观评价药品生产企业质量管理体系的方法,为监管机构对行业的监管提供了更加客观、高效的新途径。该指南可用于国内制药企业的质量宏观管理,也为监管部门今后对药品质量监管模式的发展提供参考。

Objective:To interpret the relevant guidance on quality metrics,and provide reference for the quality management of domestic pharmaceutical manufacturers and regulatory departments.Methods:The feasibility of applying quality metrics in manufacturing enterprises was discussed by reviewing and introducing the development and content of the draft guidance on quality metrics,comparing the similarities and differences between the two versions of the draft guidance,and interpreting its connotation.Results and Conclusion:FDA's draft guidance for quality metrics could provide not only an objective method for evaluating the quality management system of drug manufacturing enterprises,but also a more objective and efficient new approach for regulatory agencies to supervise the industry.The guidance may be applied by manufacturers in quality management,and could be a model for regulatory authorities to improve drug quality supervision in the future.