Abstract

Carrying out the overseas GMP (Good Manufacturing Practices) inspection is a key responsibility of the National Regulatory Agency to supervise the imported pharmaceutical products. And it’s also an important measure to maintain the safety of the pharmaceutical products used by the public. In April 2011, China began to implement the pilot work of overseas GMP inspection. Through exploration and summary, a complete set of inspection procedures and systems have been formed. In this paper, the development history of China's overseas GMP inspection is reviewed, the inspection process and the treatment of inspection results are compared with the US FDA, the EU, WHO and so on. This paper analyzes the numbers, countries and types of products in the overseas GMP inspections, which carried out by China in the past decade, makes a statistical analysis of the observations found in the inspections, discusses the areas where the observations are concentrated, and focuses on the areas where the critical observations are concentrated. Finally, the trend of overseas GMP inspection in the future is prospected.

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