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• 管理研究 • 上一篇    下一篇

制药企业药品研发阶段质量管理存在的问题及对策探讨

杜晓霞,邢花   

  1. 华北制药股份有限公司,沈阳药科大学工商管理学院
  • 收稿日期:2018-03-29 修回日期:2018-04-23 出版日期:2018-06-25 发布日期:2018-06-25

Problems and Measures of Quality Management in Drug R&D Stage of Pharmaceutical Enterprises

duxiaoxia and   

  1. North China Pharmaceutical Co., Ltd.,
  • Received:2018-03-29 Revised:2018-04-23 Online:2018-06-25 Published:2018-06-25

摘要: 通过查阅文献、法规等资料,分析我国制药企业药品研发阶段质量管理存在的问题,提出对策:制药企业应借鉴国外先进的质量管理理念和细则,结合药品研发的项目管理模式,基于药品研发工作的灵活性、创新性等特点,以及各研究阶段不同的特征与目标要求,构建良好的研发质量管理体系。逐步强化药品研发质量管理,规范药品研发,为产品成功报批奠定良好的合规基础,促进企业发展。要避免采用与研发活动严重脱节的形式化管理和全面质量管理“一刀切”的管理模式束缚药品研发。

Abstract: By consulting documents and regulations, this paper analyzes the problems in the quality management of drug reserch and development stage in the pharmaceutical enterprises and puts forward the measures:Pharmaceutical enterprises should build a good R&D quality management system, in accordance with the quality of the international advanced management idea and combining with the project management mode of pharmaceutical research. The system should be based on the flexibility, innovation of R&D and meet the target requirements of different stages of R&D. The quality management to the whole project implementation process should be gradually strengthened. The good R&D quality management system will establish a good compliance basis for the successful submission of production and promote the development of enterprises. Enterprises should avoid the formal management and the "rigid uniformity" management model of comprehensive quality management which is seriously out of step with R&D.