药品生产企业风险分级研究

Risk Classification of Drug Manufacturing Enterprises

目的 构建基于风险程度的GMP检查新模式。方法 通过文献研究并听取相关从事药品检查的专家意见,形成药品生产企业风险分级评价初级指标。使用德尔菲法设计专家问卷调查,对指标体系进行咨询,采用层次分析法对构建的风险评价指标的权重进行计算,得到药品检查全生命周期风险评价指标体系。结果 构建的药品生产企业风险分级指标体系包含3个一级指标,11个二级指标,28个三级指标。一级指标按权重排序依次为过程风险(0.539 6)、合规风险(0.297 0)和固有风险(0.163 4);二级指标排名靠前的为生产工艺的复杂性(0.294 7)、产品质量(0.165 0)和变更复杂性(0.125 4)等;特殊性质药品复杂指数(0.113 8)、共线指数(0.113 8)、非无菌药品指数(0.111 7)及关键人员变更指数(0.104 5)等为权重较高的三级指标。结论 通过制定药品生产企业风险评估模型,可以促进放管服背景下完善药品检查体系,充分利用有限的检查资源,减少对低风险药品生产企业的检查频率,从正面激励更多的企业加强风险自律,切实承担药品质量安全第一责任人的主体责任。

OBJECTIVE To construct a new model of GMP inspection based on the degree of risk.METHODS Through literature research and seek the opinions of relevant experts engaged in drug inspection,the primary indicators of risk level evaluation of drug manufacturing enterprises were formed.The expert questionnaire survey was designed using Delphi method to consult the index system,and the weights of the constructed risk evaluation indexes were calculated using hierarchical analysis in order to obtain the risk evaluation index system for the whole life cycle of drug inspection.RESULTS The constructed risk grading index system of drug manufacturing enterprises contained 3 primary indicators,11 secondary indicators and 28 tertiary indicators.The primary indicators were process risk(0.5396),compliance risk(0.2970)and inherent risk(0.1634)in order of weight;the top ranked secondary indicators were complexity of production process(0.2947),product quality(0.1650)and change complexity(0.1254);the complexity index of special nature drugs(0.1138),common line index(0.1138),non-sterile drug index(0.1117)and key personnel change index(0.1045)were the tertiary indicators with higher weights.CONCLUSION By developing a risk assessment model for drug manufacturing enterprises,it can promote the improvement of drug inspection system in the context of decentralization,make full use of limited inspection resources,reduce the frequency of inspection for low-risk drug manufacturing enterprises,and positively motivate more enterprises to strengthen risk self-discipline and effectively assume the main responsibility of being the first responsible person for drug quality and safety.