摘要
目的新药研发是企业长期发展的基础,是药品质量的源头,对药品上市后的安全起着至关重要的作用。因此,建立新药研发过程中有效的质量和风险控制是药品企业长期发展的需求。方法在药品研发不同阶段开始前引入风险评估,对药品研发过程进行质量和风险的控制。结果这种风险控制体系已在本公司运行,并已取得良好的效果。结论药品研发过程中的质量控制不仅仅是为了应对GMP认证的要求,更重要的是能将质量源于设计[1]的理念有效的融入企业的研发管理中,使其真正能为提升产品的质量服务。
Objective New drug research and development is the basis for the long-term development of the enterprises, and the source of drug quality, which plays an important role in safety of the drugs in clinical use. Therefore, it is necessary for the pharmaceutical enterprises to establish effective quality and risk control in the process of new drug research and development in order to achieve long-term development. Methods Introduce the risk assessment in drug research and development at different stages, so as to conduct process quality and risk control. Results The risk control system has been running in our company for years, and has achieved good results. Conclusion The quality control process of drug development not only meets the requirements of GMP certification; more importantly; it also effectively brings QbD （quality by design） concept in the R ＆ D management of enterprise, which can really facilitate the quality improvement of products.
出处
《中国药事》
CAS
2014年第6期595-597,共3页
Chinese Pharmaceutical Affairs
关键词
药品研发
质量控制
风险控制
drug research and development
quality control
risk control
