Asian Journal Of Social Pharmacy

Objective To reduce the risk of choosing API starting materials incorrectly since the rationality of its selection and the scientific justification of quality research have a significant impact on the quality control of API. Methods Failure mode and effects analysis (FMEA) strategy was used to do the risk management of API starting materials of D company. Results and Conclusion The FMEA method can improve the risk management of the research of API starting materials for D company, which is still effective to apply the method to C company and R company.

drug substance, starting material, risk management, FMEA