Abstract: The manufacturing quality and risk of drug is different, because the manufactring process and environment is different. This paper establishes the integrated risk evaluation system by evaluating 9 risk factors including concentration fluctuations of Omeprazole Enteric-coated Capsules through 32 factories’ products. The purpose of this system is to provide the directed supervision object for government.

Key words: omeprazole enteric-coated capsules, manufacturing quality, risk evaluation