RESUMEN
Objective:To take quality risk management as the guiding ideology and use failure mode and effect analysis ( FMEA) to evaluat the key of the whole process of cleaning validation which aimed to reduce the risk. Methods: FMEA was applied in the cleanliness verification of APIs. According to the risk priority values, the risk points and risk control measures were determined for the key validation of cleanliness verification. Results:Through the control measures, the final risk score was obtained to assess the impacts on the final product quality and patient safety. Conclusion:Quality risk management is applied in the cleanliness verification of non-sterile APIs, which can effectively verify all aspects of the process, improve the pertinence and reduce the quality system risks in the actual production process with important guiding significance.