Objective To provide a basis for drug regulatory departments to carry out regulatory activities based on production risks.Methods Based on relevant laws,regulations,literature,descriptions of change and deviation in the annual drug reports of manufacturing enterprises,the Delphi method was used to screen the indicators of risk management in drug manufacturing enterprises and establish an indicator system.The analytic hierarchy process was used to calculate the weights of each indicator by the Python 3.9 software package.The fuzzy comprehensive evaluation method was used to establish a fuzzy judgment matrix and a fuzzy evaluation model,and the verification test was conducted.Results A production risk three-level indicator system based on changes and deviations was established,including two primary indicators(changes and deviations),15 secondary indicators,and 64 tertiary indicators.The annual drug reports of 10 enterprises were randomly selected,and eight out of the ten simulated data met the threshold of risk management level(standard),with an accuracy rate of 80.00% .Conclusion The established model can effectively evaluate the risk level of quality management in drug manufacturing enterprises,and provide quantifiable reference for targeted inspections by drug regulatory departments.
changedeviationrisk managementmanufacturing enterpriseannual drug reportdrug regulation
国家科技期刊平台
NSTL
万方数据
