摘要
目的:为项目的选择和药学研究结果的真实性、有效性、完整性提供帮助。方法:从立项和药学研究两个方面,阐述项目调研和药学研究质量管理体系构建的几个关键点,为研发机构选择产品和建立完善的药学研究质量管理体系提供建议。结果:为保证立项合理以及研发工作的有序开展和规范管理,企业应当进行充分调研,并参考GMP的思路构建与研发相匹配的软件和硬件管理体系。结论:立项和药学研究是药物研发过程中很重要的两个阶段,应对其实行书面化管理,以便直观地反映出机构的研发能力和产品质量。
Objective： To provide help for project selection and authenticity, validity and integrity of results of pharmaceutical research. Methods： The article described the key points for research project and construction of quality management system of drug research and development. Suggestions for relevant companies to select products were provided, and the quality management system of drug research and development was established and perfected. Results： To ensure reasonable selection, orderly research and standardized management, R＆D institution should make full investigation, establish software and hardware management system consistent with GMP and the R ＆ D level. Conclusion： Project and drug R＆D, which are two important stages of drug development, are needed to be documented, so as to directly refl ect research and development ability of R＆D institution and the quality of the project.
出处
《中国药事》
CAS
2015年第9期895-899,共5页
Chinese Pharmaceutical Affairs
关键词
产品立项
药学研究
质量管理体系
药品注册
project
pharmaceutical research
quality management system
drug registration
