企业人力资源对药品生产质量管理水平的影响  

Effect of Human Resources on the Drug Production Quality Management in Pharmaceutical Manufacturers

作　　者：罗京京 陶群山[2] LUO Jingjing;TAO Qunshan(Anhui Center for Drug Certification and Inspection,Hefei,Anhui,China 230051;Anhui University of Chinese Medicine,Hefei,Anhui,China 230012)

机构地区：[1]安徽省药品审评查验中心,安徽合肥230051 [2]安徽中医药大学,安徽合肥230012

出　　处：《中国药业》2023年第16期6-10,共5页China Pharmaceuticals

基　　金：安徽省科技创新战略与软科学研究专项项目[202206f01050015]。

摘　　要：目的评估企业人力资源对药品生产质量管理水平的影响。方法问卷调查安徽省16个地级市的230家药品生产企业质量管理情况,建立OLS模型、Logit模型检验企业人力资源(员工数量、学历结构、年均增加人数、质量负责人变更次数)与药品生产企业《药品生产质量管理规范》(GMP)检查结果的关系。结果企业人力资源变量的OLS模型回归分析结果表明,企业员工越多,其GMP检查结果相对更好。Logit模型回归分析结果表明,企业规模越大,企业员工越多,其GMP检查结果相对更好。结论企业员工数量在一定程度上反映了企业质量管理水平的优劣,规模大、员工多的药品生产企业所产药品的质量可能更好。Objective To evaluate the effect of human resources on the drug production quality management in pharmaceutical manufacturers.Methods A questionnaire survey was conducted on the status of drug production quality management in 230 pharmaceutical manufacturers from 16 prefecture-level cities in Anhui province.The OLS model and Logit model were established to investigate the relationship between human resources(number of employees,educational structure,average annual increase in number of employees,change frequency of quality director)and the inspection results for pharmaceutical manufacturers based on the Good Manufacturing Practice(GMP).Results The OLS model of human resource variable showed that the more employees in the pharmaceutical manufacturer,the better the inspection results based on the GMP.The Logit model regression analysis showed that the larger the scale of the pharmaceutical manufacturer and the more employees there were,the better the inspection results based on the GMP.Conclusion The number of employees in a manufacturer reflects the quality management level to a certain extent,and the quality of drugs produced by pharmaceutical manufacturers with large scale and large number of employees may be better.

关 键 词：OLS模型 LOGIT模型 企业 人力资源 药品生产质量管理 

分 类 号：R95[医药卫生—药学]