An Analysis of Quality Management in Vaccine Manufacturers of China Based on the New Vaccine Administration Law

Abstract

With the application of new technologies in development and production, the quality of vaccines in China had been constantly improved, and vaccines manufactured in China were being supplied to international markets while meeting the domestic immunization program need. Meanwhile, the quality management performance of vaccine manufacturers in China was continually improving. The implementation of the Vaccine Administration Law of the People’s Republic of China had imposed legal systematic requirements on full lifecycle management of vaccines in development, production and supervision, which was of important milestone significance for guiding the development of China’s vaccine industry. Based on the understanding of this law, this article had discussed quality management of vaccines from four aspects including biosafety, application of new technologies for vaccine development and production, process changes and deviation management with practical work taken into account, intended to arouse readers’attention and discussions on this law and relevant issues and provide reference to vaccine manufacturers in production, development and product quality improvement.