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

作　　者：陈云霞 张贵芹 黄梦瑶 CHEN Yunxia;ZHANG Guiqin;HUANG Mengyao(Shandong Lukang Pharmaceutical Co.,Ltd.,Jining 272021,China)

机构地区：[1]山东鲁抗医药股份有限公司,山东济宁272021

出　　处：《化工管理》2024年第12期14-17,共4页Chemical Engineering Management

摘　　要：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.

关 键 词：药品研发 质量管理体系 制药企业 

分 类 号：TQ460[化学工程—制药化工]