Taking the process of API A of a pharmaceutical factory in Linquan County,Fuyang City,Anhui Province as an example,this study explores the application of FMEA tools in the processe development of API A.By organizing risk management activities,risk assessment,risk analysis and evaluation,risk control and risk review,potential hidden risks are resolved,and product quality risks and safety hazards are identified and eliminated,which improve the process robustness and product safety.This method can provide a basis for product development and safety management in various fields of the pharmaceutical industry.
维普
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