Objective: To analyze the key contents that foreign customers are most concerned about during the quality audit of API manufacturers, summarize the problems existing in the customer quality audit of Chinese API manufacturers and put up with the solutions for the problems in order to provide valuable suggestions for API manufacturers to actively respond to audit of foreign clients. Methods: To take the GMP audit from foreign customers of an API manufacturer in China as an example, the problems existing in the customer quality audits of the enterprise were analyzed, and the corresponding solutions and suggestions were put forward after analyzing the problems. Results and Conclusion: The defective items involved in foreign customer quality audits of the API manufacturer mainly lay in quality management, material management, process equipment, workshop buildings and facilities, documentation, production management validation, etc. The enterprises should strengthen self-inspection and actively participate in GMP certifications of foreign regulatory agencies, so as to continuously improve their own quality management level.