药物研发质量管理体系的构建_鱼刚.pdf

895 1 2 R95 A 1002-7777(2015)09-0895-05 doi:10.16153/j.1002-7777.2015.09.002 Construction of Quality Management System of Drug Research and Development 1 2 Yu Gang , Yang Wenye (1. Suzhou Pharmavan Cancer Research Center Co., Ltd, Suzhou 215125, China; 2. Suzhou Teray Pharmaceutical Co., Ltd, Suzhou 215151, China) Abstract 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, RD institution should make full investigation, establish software and hardware management system consistent with GMP and the R D level. Conclusion: Project and drug RD, which are two important stages of drug development, are needed to be documented, so as to directly refl ect research and development ability of RD institution and the quality of the project. Keywords: project; pharmaceutical research; quality management system; drug registration