摘要:
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.
Chen Xiaofeng, Chen Yuwen.
Study on Risk Management of API Starting Materials Based on FMEA
[J]. 亚洲社会药学, 2026, 21(1): 60-69.
Chen Xiaofeng, Chen Yuwen.
Study on Risk Management of API Starting Materials Based on FMEA
[J]. Asian Journal of Social Pharmacy, 2026, 21(1): 60-69.