| 程英,汪飞,黄丽晶,石江涛,刘超.药物研发全过程质量管理体系的构建和运行[J].中国药事,2021,35(6):631-640 |
| 药物研发全过程质量管理体系的构建和运行 |
| Construction and Operation of Quality Management System in the Whole Process of Drug Research and Development |
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| DOI：10.16153/j.1002-7777.2021.06.004 |
| 中文关键词: 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 |
| 英文关键词: quality management system of the whole process of drug R & D risk assessment management elements safety effectiveness quality control |
| 基金项目: |
| 作者 | 单位 | | 程英 | 河北菲尼斯生物技术有限公司,石家庄自身免疫药物技术创新中心,河北省自身免疫病药物研究重点实验室,石家庄 050035 | | 汪飞 | 河北菲尼斯生物技术有限公司,石家庄自身免疫药物技术创新中心,河北省自身免疫病药物研究重点实验室,石家庄 050035 | | 黄丽晶 | 河北菲尼斯生物技术有限公司,石家庄自身免疫药物技术创新中心,河北省自身免疫病药物研究重点实验室,石家庄 050035 | | 石江涛 | 河北菲尼斯生物技术有限公司,石家庄自身免疫药物技术创新中心,河北省自身免疫病药物研究重点实验室,石家庄 050035 | | 刘超 | 河北菲尼斯生物技术有限公司,石家庄自身免疫药物技术创新中心,河北省自身免疫病药物研究重点实验室,石家庄 050035 |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. |
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