| ObjectiveIn recent years,the drug regulatory system of our country has been gradually improved,and the supervision of pharmaceutical companies has gradually become more standardized,intensive,and innovative.With the introduction of the new version of the GSP,the state has put forward higher quality management requirements for pharmaceutical companies.The new version of the GSP has added many new concepts in the supervision,such as corporate internal audit and risk point control,total quality management,computer system control,cold chain control and so on.In order to fully understand the on-site inspection of the new version of the GSP,to identify high-frequency sub-defective items that existed in the company and identify common risk points that existed in the company,statistics were collected on the spot inspection of defective items in the Beijing pharmaceutical wholesale enterprises.To explore the factors that affect the severity of high-frequency sub-defective items and how to control drug quality risks in the process of operation by analyzing the high-frequency defect project differences,so as to provide reference standards for the regulatory authorities to further improve inspection quality.MethodsIn this study,a literature review method was used to collect information on sub-defective items from the new version of the GSP in Beijing pharmaceutical wholesale enterprises.According to the principles of GSP inspection,descriptive statistics were used to summarize the frequency of defective items in each chapter.Each chapter was analyzed during the inspection process.The specific forms of expression and major issues in the company determine the high-frequency sub-defective items of the company through the proportion of frequency and defect rate.The screening and removal of data were conducted using inspection categories and inspection items as key variables.Companies that also accepted certification inspections and follow-up inspections were selected as research objects for high frequency sub-defective project discrepancy analysis and influencing factor analysis,using the Chi-square test,Kruskal-Wallis H-rank test analysis of high-frequency sub-defective items in Beijing pharmaceutical wholesale enterprises,to explore the causes of the differences;using disordered logistic regression analysis Methods To investigate the influencing factors of the occurrence frequency of high-frequency sub-defective items in an enterprise,and to use the ordinal logistic regression method to investigate the influencing factors of the severity of high-frequency sub-defect items in the company.Results1.The on-site inspection of the new version of the GSP of the Beijing pharmaceutical wholesale enterprise has 2612 frequency of defective items,including 6 items of serious defects,51 frequency;90 items of major defects,1431 frequency;108 items of general defects,1130 frequency.The top five areas with higher defect rates are the quality management system,quality management system documentation,personnel and training,computer systems,and procurement.The computer system is the most frequently accounted for with the most severely-defective projects.The highest proportion of major defect items and general defected items is the quality management system.The total frequency of defective items accounting for more than 10%is the quality management system(24.96%),quality management system documents(16.65%),personnel and training(10.91%).2.In terms of quality management system,there is no significant difference in the frequency of enterprises of different scales and regions.While there are significant differences in the frequency in different business scopes,inspection categories,and inspection time;the quality management system documents and staff and training are different.In terms of scale,scope of business,region,and inspection time,there was no significant difference in the frequency,and in different inspection categories,there was a significant difference in frequency.3.The scale and scope of the business are not the influencing factors of the occurrence frequency of high-frequency sub-defect items,and the enterprise scale is the influencing factor of the severity of high-frequency sub-defect items,and it is significantly positively correlated with the severity of high-frequency sub-defect items.ConclusionsThe study concludes that the high-frequency defective items on-site inspection of the new version of the GSP in Beijing drug wholesale enterprises are mainly concentrated in the three sections of the quality management system,quality management system documentation,personnel and training,and the top five terms for frequency are*01710(102 Frequency),01101(91 frequency),*03601(88 frequency),*03701(87 frequency),01001(76 frequency),mainly reflected in the quality management department’s review of the computer system operating authority is not in place,quality database update is not In a timely manner,enterprises are incomplete in risk point finding and risk control,and the establishment of enterprise system and position personnel responsibilities is not sufficiently detailed,and there is a situation that is inconsistent with the actual operation of the company.Beijing pharmaceutical wholesale enterprises have significant differences in the frequency of high-frequency sub-defective items.The frequency of defects found in certification inspections is higher than the frequency of defective items in enterprises undergoing follow-up inspections;enterprises with different business scopes and different inspections There are significant differences in the frequency of defective quality management system projects among enterprises in time;there is no significant difference in the frequency of high-frequency sub-defective projects between enterprises of different sizes and in different regions.There is a significant positive correlation between the scale of enterprises and the severity of high-frequency sub-defective projects.The larger the scale of enterprises is,the higher the severity of high-frequency sub-defective projects,and they are mostly major defects.The smaller the scale of enterprises is,the higher the number of substandard defects the lower the severity,the more common defects are. |
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