The research team of drug safety rectification of State Food and Drug Administration, under the leadership of Wang Baoting, Director of the Department of Medical Devices of State Food and Drug Administration, arrived at YRPG on April 21 to carry out the survey on specific issue. Principals from the Food and Drug Administration at the provincial and municipal level as well as enterprise principals accompanied during the survey.
The research team listened to the group’s report on drug safety rectification and deepened the survey in the warehouse, frozen powder injection agent workshop and quality testing center to understand in detail the drug production, storage and testing of the enterprise. For many years, YRPG has actively referred to international advanced management concept, continued to perfect the long-term quality management system, promoted and implemented the quality authorized person system in an all-round way, persisted in quality control from the beginning by adhering to the principle of “the drug is designed and produced rather from testing” so as to implement the quality responsibility to each workshop, each employee and each procedure, and eliminate any element and hidden trouble which may affect the product’s quality in the embryonic stage.
The research team fully recognized YRPG’s measures of establishing a complete and strict quality guarantee system, intensifying the quality management and testing, and practically guaranteeing the sufferers’ safe medication; required the enterprise to further strengthen the employees education and training, improve the employees’ drug safety concept and produce drugs strictly according to the operation flow so as to guarantee the drug quality from the very beginning. At the same time, the research team also encouraged the enterprise to intensify the talent cultivation and independent R&D so as to upgrade the products core competiveness.
The nationwide drug safety specific rectification was organized and developed with joint efforts of six departments of Ministry of Health for two years. The drug safety rectification of Jiangsu Province was started from July 2009 to June 2011.