Abstract: OBJECTIVE To provide reference for drug manufacturers to more effectively implement drug production quality management practices and ensure drug quality and safety by analyzing the rules and characteristics of the defects of the drug manufacturers whose GMP certificates have been withdrawn. METHODS The defects of Chinese patent medicine and chemical preparation drug manufacturers whose GMP certificates were withdrawn from 2016 to 2019 in China, and their trend of changes year by year were reviewed and analyzed. RESULTS The cumulative frequency of defect items of 125 companies was 855, involving 17 chapters of GMP text and its appendix. Defective items mainly focused on the six aspects of doubtful data reliability, unauthorized changes to process regulations, falsification, confusion in material management, ineffective operation of deviation management systems, and inability of key personnel to perform their duties effectively. From 2016 to 2018, the proportion of defective projects in production management, institutions and personnel, equipment and plant facilities showed a downward trend year by year, while in the quality control and quality assurance section, the proportion of defective items showed a significant increase trend, and the defects in the confirmation and verification chapter also showed an upward trend. Except for the data reliability issues involved in the computerized system and the defective items of deviation processing, the proportion of other defective items in the enterprises had basically shown a downward trend year by year. CONCLUSION Pharmaceutical manufacturers assume primary responsibility for drug quality. They should put the concept of risk management throughout the whole product life cycle, adhere to the principle of honesty and trustworthiness, constantly strengthen data integrity management, pay attention to targeted training of employees, improve the quality awareness of all staff, establish quality management system on the basis of product risk assessment and ensure its effective implementation and continuous improvement.