亚洲社会药学 ›› 2026, Vol. 21 ›› Issue (1): 60-69.

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Study on Risk Management of API Starting Materials Based on FMEA

  

  • 出版日期:2026-03-25 发布日期:2026-03-25

Study on Risk Management of API Starting Materials Based on FMEA

  • Online:2026-03-25 Published:2026-03-25

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.

关键词:

Abstract:

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.

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