Application of Failure Mode and Effects Analysis in Active Pharmaceutical Ingredient(API) Process Validation

OBJECTIVE To explore the application of risk management tools in the API process validation, using failure mode and effects analysis (FMEA), evaluate the key process parameters, reduce the risk of validation. METHODS FMEA applied to the process validation of API, according to the size of the RPN value, to determine the key process parameters and risk control measures. RESULTS By implementing and tracking process operation control measures, and once again calculate RPN value, reduced than before validation, reduced the risk of process deviation occurs. CONCLUSION Quality risk management is applied to the API process validation, which can effectively improve the pertinence, reduce the system risk of the production quality, will be conducive to smooth running of daily commercial production, improve production efficiency.