According to the 2017 annual drug inspection report, it is a "big problem" to fail to meet GMP requirements

Source: health news.com.2018-06-11 Recently, the 2017 annual drug inspection report issued by the State Food and Drug Administration pointed out that among the problems found in the field inspection of drug registration and production in 2017, there were many GMP compliance problems before the approval for listing, which indicated that the quality management system of the enterprise was relatively weak in the process of drug research and development, not enough attention was paid to the GMP compliance, and there was production quality control in the process of research and development Problems such as insufficient specification implementation, insufficient deviation and over standard investigation, unscientific process verification, etc According to the report, in 2017, the former State Food and Drug Administration organized 751 on-site inspections of drug registration and production, on-site inspections of generic drug conformity assessment, GMP follow-up inspection, flight inspection, on-site inspections of overseas production of imported drugs, circulation inspection and international inspection In 2017, the former State Food and Drug Administration completed 428 GMP follow-up inspections (478 times), a year-on-year increase of 234% There are 37 enterprises with inconformity, accounting for 8.6%; 108 enterprises with warning letters, accounting for 25% The causes of non conformance include serious violation of GMP, suspected violation of laws, unstable product quality and other factors The most defects found in the quality control and quality assurance part account for 28% of all defects, followed by document management, accounting for 16% and equipment, accounting for 10% In 2017, 57 GMP flight inspections were carried out, involving 21 provinces (cities) There are 39 enterprises with problems, accounting for about 68%, among which 27 enterprises with serious problems are required to withdraw GMP certificates or file for investigation According to the report, in 2017, 55 drug wholesale enterprises were tracked and inspected, covering 20 provinces (regions and cities); 12 retail pharmacies in Liaoning, Hunan and Guizhou were also flying inspected Among them, 19 drug wholesalers failed to pass the inspection, with a failure rate of 34.5%; 10 drug stores failed to pass the flight inspection, with a failure rate of 83.3% Compared with 2016, the passing rate of 55 wholesale enterprises reached 65.5%, indicating that the compliance awareness of drug circulation industry is gradually increasing, and the number of violations is gradually decreasing.