制药企业研发机构质量管理体系构建的建议

Suggestions on Quality Management System of R&D Organizations in Pharmaceutical Firms

目的:为制药企业研发机构构建质量管理体系提供建议。方法:基于制药企业研发机构质量管理体系构建的必要性,对构建过程中的若干问题提出几点建议。结果与结论:制药企业研发机构应加强质量意识、团队建设、人才培养和文件编写,构建质量管理体系,提高研发工作效率,保障研发产品质量。

Objective： To put forward suggestions for the establishment of quality management system of RD organization in pharmaceutical firms. Methods： Based on the necessity of establishing quality management system of RD organization, some suggestions for solutions to problems are put forward in this paper. Results and Conclusion： RD organization needs to establish an effective quality management system by strengthening quality consciousness, perfecting team building, consolidating personnel training, and rephrasing document compiling, so as to assure the quality of RD work.