摘要
目的:为药物研发实验室质量管理体系的构建和运行提供建议,协助研发工作规范、科学地进行,提高研发质量和效率。方法:本文梳理了药物研发相关的规范要求,介绍了药物研发质量管理体系建立的作用及现状,重点阐述了药物研发全过程的各管理要素,并就各个实验室的异同点进行了分析。结果与结论:药物研发全过程质量管理体系中风险评估控制应贯穿药物研发的始终,各实验室应对相关管理要素进行充分理解、规范和有效执行,并持续改进,从而保证研发药品的安全、有效和质量可控。
Objective: To provide suggestions for the construction and operation of the quality management system of drug R & D laboratories, to assist R & D work in a standardized and scientific way and to improve the quality and efficiency of R & D. Methods: In this paper, the regulatory requirements related to drug R &D were combed, the role and current situation of the establishment of quality management system of drug R &D were briefly introduced, the management elements of the whole process of drug R & D were emphatically elaborated, and the similarities and differences of each laboratory were analyzed. Results and Conclusion: In quality management system of the whole process of drug R & D, risk assessment and control should run through the whole process, all laboratories should fully understand, standardize and effectively implement relevant management elements and continuously improve them so as to ensure the safety, effectiveness and quality control of researching and developing drugs.
作者
程英
汪飞
黄丽晶
石江涛
刘超
Cheng Ying;Wang Fei;Huang Lijing;Shi Jiangtao;Liu Chao(Hebei Fitness Biotechnology Co.,Ltd.,Shijiazhuang Autoimmune Drug Technology Innovation Center,Hebei Key Laboratory of Autoimmune Drugs,Shijiazhuang 050035,China)
出处
《中国药事》
CAS
2021年第6期631-640,共10页
Chinese Pharmaceutical Affairs
关键词
药物研发全过程质量管理体系
风险评估
管理要素
安全
有效
质量可控
quality management system of the whole process of drug R&D
risk assessment
management elements
safety
effectiveness
quality control
