International Drug Inspection and Observation of Chinese Chemical Pharmaceutical Production Enterprises
Objective To promote the improvement of quality management capabilities in Chinese chemical pharmaceutical production enterprises.Methods The international drug inspection and observation of Chinese chemical pharmaceutical production enterprises from 2015 to 2022,and the distribution of defects found during inspection were analyzed.The key points of international drug inspection and the categories of high-frequency defects were summarized.Results From 2015 to 2022,24 overseas pharmaceutical regulatory agencies completed 443 international inspection of Chinese chemical pharmaceutical production enterprises,and found 4 854 defects.From 2015 to 2019,the number of inspections from overseas pharmaceutical regulatory agencies increased year by year,with 74,81,84,82,and 102 times,respectively.From 2020 to 2022,the number of overseas inspections significantly reduced because of the COVID-19 epidemic,with 6,6 and 8 times,respectively.From 2015 to 2019,the World Health Organization(WHO),European Directorate for the Quality of Medicines(EDQM),and Food and Drug Administration(FDA)found 20,20,and 5 defects per inspection,respectively.Serious defects were mainly caused by data reliability issues,but the proportion of occurrences decreased year by year.In 2019,the Center for Food and Drug Inspection of NMPA inspected 102 overseas pharmaceutical regulatory agencies and found 793 defects.The Top three high-frequency defects were quality control and assurance,document management,confirmation and verification,accounting for 32.53%,14.88%,and 13.75%,respectively.Conclusion The inspection focus and high-frequency defect categories of different overseas pharmaceutical regulatory agencies are basically similar.There is still a gap between Chinese chemical pharmaceutical production enterprises and the international level in terms of quality control and assurance,confirmation and verification,and document management.Chinese pharmaceutical production enterprises should continuously improve their production quality management level based on the actual situation.China's pharmaceutical regulatory authorities should conduct in-depth drug inspections based on the aforementioned risks,and promote the comprehensive improvement of enterprise quality management capabilities.
chemical medicineinternational drug inspection and observationGood Manufacturing Practice of Medical Products
万方数据
维普
