制药企业研发质量管理体系存在的问题及对策

Problems and Countermeasures of Research and Development Quality Management System in Pharmaceutical Enterprises

近年来,药品研发发展迅速,为保证药品研发过程的科学性、规范性、真实性,从而最大程度降低药品上市销售后的风险,研发质量管理体系的完善尤为重要。文章主要分析了制药企业研发质量体系的现状以及改善措施,对企业制造安全有效、质量可控的药品、保障病患者健康、造福人类具有深远意义。

In recent years,drug research and development work has developed rapidly.In order to ensure the scientificity,standardization and authenticity of the research and development process,so as to minimize the risk after drug marketing,it is particularly important to improve the research and development quality management system.This article mainly analyzes the current situation and improvement measures of the research and development quality system in pharmaceutical enterprises,which has profound significance for manufacturing safe and effective drugs with controllable quality,ensuring the health of patients and benefiting humanity.