Situation analysis of GMP follow-up inspection in vaccine manufacturers

Abstract

Objective To evaluate current situation of GMP management in domestic vaccine manufacturers through GMP follow-up inspections and analysis of observations. Methods According to the yearly inspection plan by Department of Drug and Cosmetics Supervision in China Food and Drug Administration (CFDA), inspectors from Center for Food and Drug Inspection in CFDA were assigned to perform GMP follow-up inspections at 36 vaccine manufacturers throughout the country in 2016. Results The inspections observed a total of 421 defects, including 38 major defects and 383 minor defects. Conclusion In general, domestic vaccine manufacturers implement the requirement of GMP, but management still needs improvement. Manufacturers should continue to raise quality management ability to ensure the vaccine quality. Key words: Good manufacturing practice; Vaccine manufacturers; Defects