基于药品企业质量风险大数据的现场监管策略优化研究OACSTPCD

On-site supervision is a risk-based regulatory system that requires the scientific development of supervision plans for quality risks and hidden dangers in pharmaceutical enterprises,the rational allocation of supervision resources based on their risk levels,and the implementation of classified supervision measures.In this study,the quality risk monitoring business support system is set up for pharmaceutical enterprises by establishing the quality risk expert database and quality risk monitoring index system for pharmaceutical enterprises based on the difficulty analysis of on-site drug supervision.Based on this support system,the quality risk classification method,the differentiated spot check strategy and business auxiliary visualization system are established.This support system is used to learn the risk level of pharmaceutical enterprises,so as to innovate supervision methods and optimize monitoring strategies.Taking Jiangxi Province as an example,it is verified that the support system can guide the risk assessment of sample enterprises,can improve the targeting of on-site drug supervision in the process of technical review,scheme editing,on-site implementation and comprehensive evaluation,and can effectively improve the quality and efficiency of supervision.