安徽省药品生产企业质量受权人结构现状调研分析

Investigation and analysis on the structure status of the quality authorized person in drug manufacturers of Anhui Province

目的:调研安徽省药品生产企业质量受权人结构现状,为建立符合我国国情并与国际接轨的质量受权人制度提供一些借鉴及思路。方法:通过对安徽省药品生产企业质量受权人从性别、年龄、学历、专业、职称、从业年限、同一企业工作年限、外出培训、职务兼任以及行政级别结构现状等进行调研分析、比较。结果:安徽省药品生产企业质量受权人存在高学历和高级专业技术职称人员数量较少、质量受权人流动频繁、企业不重视质量受权人的培训和继续教育以及质量受权人在企业的权威性不高等问题。结论:建议行业主管部门应确立质量受权人的法律地位和建立职业化质量受权人体系,社会组织和企业自身应强化对质量受权人的培训和继续教育。

Objective:To investigate the structure status of the quality authorized person in drug manufacturers of Anhui Province,and to provide some references and thoughts for the establishment of the drugs system of the quality authorized person in line with national conditions and international practice.Methods:The quality authorized person of pharmaceutical production enterprises in Anhui Province were investigated,analysed and compared from the aspects of gender,age,educational background,major,technical title,working years,working years of the same enterprise,external training,concurrent positions and administrative levels.Results:It objectively reflected the problems that the quality authorized person in Anhui Province had a small number of personnel with high level of education and senior technical titles,and frequent flow of the quality authorized person,and the enterprises did not attach importance to the training and continuing education,and the low authority of the quality authorized person in the enterprises and so on.Conclusions:It is suggested that the administration department should establish the legal status and the professional system of the quality authorized person,and the social organizations and the enterprises themselves should strengthen the training and continuing education of the quality authorized person.