对新兴制药企业质量管理规范建设的思考

Thinking on Construction of Quality Management Standards in Emerging Pharmaceutical Companies

目的研讨制药企业质量管理的意义和方法,以期为那些正在着手建设规范化管理制度的新兴制药企业提供良好的建议。方法从质量管理概念入手,结合新建制药企业各个环节容易出现的质量管理问题,有针对性地进行阐述和分析。结果与结论建设一个全面、全员意义上的高水平质量管理体系,是保障企业最终产品质量、实现商业价值的必要手段和条件。

Objective Through the analysis of importance and methods of quality management,to give suggestions to those new enterprises who devote themselves to establish standardized quality management.Methods Starting from the concept of quality management,and combining the possible problems of quality management,to expound and analysis the importance of good quality management system in a new enterprise.Results and Conclusion A comprehensive and high level quality management system is the necessary means and conditions,to ensure the final product quality and final commercial value of a new pharmaceutical enterprise.